Safety and dose flexibility clinical evaluation of intravesical liposome in patients with interstitial cystitis or painful bladder syndrome. A combined intravesical therapy with hyaluronic acid and chondroitin for refractory painful bladder syndrome/interstitial cystitis Multimodal therapy for painful bladder syndrome / interstitial cystitis: pilot study combining behavioral, pharmacologic, and endoscopic therapies. Results of endovesical hyaluronic acid/chondroitin sulfate in the treatment of Interstitial Cystitis/Painful Bladder Syndrome. The Clinical Effectiveness of Intravesical Sodium Hyaluronate (Cystistat®) in Patients with Interstitial Cystitis/Painful Bladder Syndrome and Recurrent Urinary Tract Infections Intravesical hyaluronic acid and alkalinized lidocaine for the treatment of severe painful bladder syndrome/interstitial cystitis Treatment of interstitial cystitis with Cystistat®, A hyaluronic acid product A multicenter, randomized, double-blind, parallel group pilot evaluation of the efficacy and safety of intravesical sodium chondroitin sulfate versus vehicle control in patients with interstitial cystitis/painful bladder syndrome. Research criteria versus clinical criteria for interstitial cystitis. Etiology, pathogenesis, and diagnosis of interstitial cystitis. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. Transdermal posterior tibial nerve laser therapy is not effective in women with interstitial cystitis. Botulinum toxin a has antinociceptive effects in treating interstitial cystitis. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Combined intravesical sodium hyaluronate/chondroitin sulfate therapy for interstitial cystitis/bladder pain syndrome: a prospective study Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain. Impact of intravesical hyaluronic acid and chondroitin sulfate on bladder pain syndrome/interstitial cystitis Intravesical hyaluronic acid in the treatment of refractory interstitial cystitis. Increased risk of bladder cancer following diagnosis with bladder pain syndrome/interstitial cystitis. A placebo-controlled study of intravesical pentosanpolysulphate for the treatment of interstitial cystitis. Multiple Intravesical Instillations of Low-Dose Resiniferatoxin in the Treatment of Refractory Interstitial Cystitis Treatment of interstitial cystitis with a quercetin supplement. Psychometric analysis of the University of Wisconsin Interstitial Cystitis Scale: implications for use in randomized clinical trials. Bladder Pain Syndrome Treated with Triple Therapy with Gabapentin, Amitriptyline, and a Nonsteroidal Anti-Inflammatory Drug Association between response to pentosan polysulfate sodium therapy for interstitial cystitis and patient questionnaire-based treatment satisfaction* Effect of intravesical glycosaminoglycan substitution therapy on bladder pain syndrome/interstitial cystitis, bladder capacity and potassium sensitivity A real‐life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis Does Cryotherapy Improve Outcomes With Soft Tissue Injury? Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) Long-term results of amitriptyline treatment for interstitial cystitis. Comparative assessment of maximal bladder capacity, 0.9% NaCl versus 0.2 M Kcl, for the diagnosis of interstitial cystitis: a prospective controlled study. Do cystometric findings predict the results of intravesical hyaluronic acid in women with interstitial cystitis? A randomized double‐blind placebo‐controlled crossover trial of the efficacy of l‐arginine in the treatment of interstitial cystitis A Pilot Open Label Study of Cystoprotek® in Interstitial Cystitis Time to initiation of pentosan polysulfate sodium treatment after interstitial cystitis diagnosis: effect on symptom improvement. Chondroitin sulfate for interstitial cystitis. Intravesical instillation of hyaluronic acid prolonged the effect of bladder hydrodistention in patients with severe interstitial cystitis. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. Hydroxyzine therapy for interstitial cystitis. A prospective, double‐blind, randomized cross‐over study evaluating changes in urinary pH for relieving the symptoms of interstitial cystitis A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis. Psychometric validation of the O'leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Intravesical Bacillus Calmette-Guerin for treatment of refractory interstitial cystitis. Long-term experience with pentosanpolysulfate in interstitial cystitis. The Agewell trial: a pilot randomised controlled trial of a behaviour change intervention to promote healthy ageing and reduce risk of dementia in later life Prevalence of clinically confirmed interstitial cystitis in women: a population based study in Finland. Effects of periodontal non-surgical therapy plus azithromycin on glycemic control in patients with diabetes: a randomized clinical trial. The PRICE study (Protection Rest Ice Compression Elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946] Efficacy of oral doxepin and piroxicam treatment for interstitial cystitis. Methods for therapeutic trials in COPD: lessons from the TORCH trial Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy. The dual serotonin and noradrenaline reuptake inhibitor duloxetine for the treatment of interstitial cystitis: results of an observational study. Helicobacter pylori infection in clinical practice: probiotics and a combination of probiotics + lactoferrin improve compliance, but not eradication, in sequential therapy.
To present single institution open-label experience with intravesical liposomes ( LPs ) , a mucosal protective agent , in patients with interstitial cystitis/painful bladder syndrome ( IC/PBS ) and to assess the safety and efficacy on IC/PBS symptoms . A total of 17 symptomatic IC/PBS patients were treated with intravesical LPs ( 80mg/40mL distilled water ) once a week for 4 weeks ( n=12 ) or twice a week treatment for 4 weeks ( n=5 ) . The primary outcome was the change in the O'Leary-Sant Symptom/Problem score and O'Leary-Sant total Score from baseline to Week 4 and Week 8 . Other outcome measurements included the changes in pain scale , urgency scale , voiding log , and patient global assessment . Both weekly and biweekly LP instillation regiments were well tolerated . The incidence of urinary incontinence , retention , or unanticipated adverse changes was not noted at any dose either during the treatment or at the 4-week follow-up . The O'Leary-Sant Symptom/Problem score , O'Leary-Sant total Score , and pain score were significantly improved from baseline at both dose regimens with added benefit with the biweekly regimen . Intravesical LPs treatment is safe and its efficacy has sustained duration . Furthermore large-scale , placebo-controlled studies are warranted to assess the efficacy for this promising new treatment for IC/PBS The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid ( HA ) 1.6 % and chondroitin sulfate ( CS ) 2.0 % in patients with refractory painful bladder syndrome/interstitial cystitis ( PBS/IC ) and to observe their impact on Quality of Life . Twenty-three women were enrolled . They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months . Mean follow-up after completion of therapy was 5 months . We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency ( p = 0.045 ) , urgency ( p = 0.005 ) , and pain ( p = 0.001 ) . The O’Leary – Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index result ed in a significant improvement in both scores ( p = 0.004 and 0.01 , respectively ) . The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score ( p = 0.001 ) . This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC PURPOSE We evaluated the effectiveness of combining behavioral therapy , pharmacologic therapy and endoscopic hydrodistension for treating  painful bladder syndrome / interstitial cystitis ( PBS/IC ) .  MATERIAL S AND METHODS Twenty-five patients with PBS/IC were prospect ively enrolled in a pilot multimodal behavioral , pharmacologic and endoscopic treatment protocol . Behavioral modification included diet recommendations , fluid restriction to 64 oz . /day , progressive timed voiding and Kegel exercises . Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg , hydroxyzine 10 - 20 mg and urised 4 tablets .  Patients underwent endoscopic bladder hydrodistention under anesthesia  at least 2 weeks after protocol enrollment . Behavioral and pharmacological treatments were continued after the hydrodistention . O'Leary-Sant question naire scores were recorded before starting the protocol , after pharmacologic/behavioral therapy , 2 months post-hydrodistension , and at scheduled follow-up . RESULTS Eighteen patients ( 72 % ) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months . All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters .  Mean O'Leary-Sant symptom index scores for baseline symptoms , after behavioral/pharmacologic treatment , post-hydrodistension and during follow up were 12.5 , 8.6 , 7.0 , and 6.7 ( p < 0.05 ) . Mean O'Leary-Sant problem index scores for baseline , after behavioral/pharmacologic treatment , post-hydrodistention and during follow up were 12.7 , 8.9 , 6.7 , and 7.7 ( p < 0.05 ) . CONCLUSION Our pilot multimodal protocol of behavioral modification , pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores , compared to a pre-treatment baseline . These results should be vali date d in a larger , placebo controlled trial OBJECTIVES The aim of our study was to test the effect of a more viscous compound than existent hyaluronic acid formulation in helping to restore a defective glycosaminoglycan layer , and therefore in improving Interstitial Cystitis/Painful Bladder Syndrome ( IC/PBS ) symptoms when administered intravesically in IC/PBS patients . METHODS A total of 23 female patients completed the study . Patients received endovesical administration of hyaluronic acid and chondroitin sulfate in normal saline , 40 ml , weekly for 12 weeks and then bi-weekly for 6 months , if there was initial response . RESULTS After 12 weeks treatment both Interstitial Cystitis Symptom and Problem Index ( ICSI/ICPI ) , pelvic pain and Urgency/Frequency Symptom Scale ( PUF ) showed a mean significant improvement , which was maintained thereafter . The average number of voidings and mean voiding volumes revealed significant improvement after the 12 weeks ' treatment period , with a significant reduction and increase , respectively . Mean voiding volume increased from 143 ml to 191 , which apparently was not reflected in a corresponding reduction of number of daily voids ( from 15,5 to 14 ) . VAS values decreased from 5,4 to 3,6 ( pain ) and from 6,0 to 3,5 ( urgency ) after the treatment cycle , showing a significant improvement . CONCLUSIONS In our preliminary experience , the administration of intravesical hyaluronic acid plus chondroitine sulphate appears to be a safe and efficacious method of treatment in IC/PBS Objective : Painful bladder syndrome/interstitial cystitis ( PBS/IC ) and recurrent urinary tract infections ( UTI ) are clinical ly challenging conditions to manage in patients . We evaluate the clinical use of intravesical sodium hyaluronate ( Cystistat ® ) in both these patient groups who have completed treatment . Patients and Methods : Thirteen patients with recurrent UTIs ( Group I ) and 8 patients with PBS/IC ( Group II ) received intravesical sodium hyaluronate ( Cystistat ® ) . Preinstallation demographic parameters were statically comparable in both groups . The mean age of presentation was 54.6 years in Group I and 57.5 years in Group II ( p = 0.9 ) . All 13 patients in Group I were on low dose antibiotics . The mean number of installations completed in both groups was 9 ( range 4–21 ) . Results : Data was collected prospect ively using a st and ard pre- and post-treatment question er with the pelvic pain and urinary/frequency patient symptom scale . At a mean follow-up of 21 months a significant improvement in bladder pain ( p = 0.05 ) , daytime frequency ( p = 0.03 ) and quality of life ( p = 0.02 ) was noted in patients in Group I. Two patients had breakthrough UTIs during treatment . Within Group I , 7 ( 53 % ) patients responded well to treatment . Patients in Group II had a significant improvement in bladder pain ( p = 0.02 ) , urgency ( p = 0.01 ) , nocturia ( p = 0.01 ) and quality of life ( p = 0.04 ) . Within Group II , 6 patients ( 75 % ) responded to treatment . Conclusion : Intravesical sodium hyaluronate ( Cystistat ® ) can be used with minimal side effects and good compliance in both groups of patients with PBS and recurrent UTIs . Longer follow-up and larger patient numbers in both groups will be required to confirm the long-term efficacy of these two clinical ly challenging groups of patients Introduction and hypothesisIntravesical instillation of hyaluronic acid ( HA ) may restore the integrity of glycosaminoglycan layer in patients with painful bladder syndrome/interstitial cystitis ( PBS/IC ) , and the benefit may be improved with addition of alkalinized lidocaine ( AL ) . Methods 48 women with severe PBS/IC who failed oral medications were enrolled and divided into one trial and two control groups . The trial group received intravesical 40 mg HA , 10 ml of 2 % lidocaine and 5 ml of 8.4 % sodium bicarbonate on a weekly basis for 8 weeks and then monthly for 4 months with a subsequent follow-up of 24 weeks , while the two control groups received 40 mg HA and mixture of 10 ml of 2 % lidocaine and 5 ml of 8.4%sodium bicarbonate respectively following the same procedure . Response to therapy was evaluated by Global Response Assessment , voids per day , Visual Analogue Scale for pain , frequency and urgency , O’leary-Sant Interstitial Cystitis Symptom Index and Problem Index , cystoscopy and bladder capacity . Results Overall 45 patients finished this study protocol . The HA + AL group and the AL group showed significant improvement at week 2 ( P < 0.01 ) , while the HA group began to show effect at week 4 ( P < 0.01 ) . There was no improvement in the AL group at week 24 and these patients quitted the study without follow up . Contrarily , the HA + AL and HA group kept on improving till the end of the study without significant difference between the two groups . Conclusions Intravesical instillation of HA and AL may provide both immediate and sustained relief of symptoms in severe PBS/IC in this preliminary study Objective . To determine whether intravesical hyaluronic acid is effective in reducing the urinary frequency and pain associated with interstitial cystitis/painful bladder syndrome ( IC/PBS ) . Material and methods . In a prospect i ve , unblinded , uncontrolled pilot study , 20 patients ( age range 34–80 years ) , all suffering from IC/PBS , received weekly bladder instillations of hyaluronic acid for 1 month and monthly instillations for a further 2 months . Patients were then offered further monthly instillations and all were subsequently evaluated after 3 years . Patient outcomes assessed were urinary frequency , use of analgesics and pain . Results . All patients completed the 3 months of hyaluronic acid treatment with mean decreases in nocturia and pain of 40 % and 30 % , respectively , and a decrease in analgesic use . Thirteen patients ( 65 % ) responded to treatment ( responders ) and continued therapy , while seven patients withdrew , six because of a lack of response and one due to cystectomy . In the 13 patients who continued hyaluronic acid instillations , four complete responders ( 30 % ) ceased therapy after a strong positive response ( 36 % , 60 % and 81 % decreases compared to baseline in day-time voids , night-time voids and pain scores , respectively ) which was maintained in the absence of continuous therapy , while after 3 years seven partial responders ( 35 % ) were still on therapy ( 25 % and 43 % decreases compared to baseline in day-time voids and pain scores , respectively ) . Two patients developed other diseases during follow-up and showed no response to long-term therapy . Hyaluronic acid was well tolerated by all patients . Conclusion . Hyaluronic acid safely reduced the pain and , to a lesser degree , the urinary frequency associated with IC OBJECTIVE The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome ( IC/PBS ) . METHODS This was a prospect i ve , r and omized , double-blind , inactive vehicle-controlled , 12-week study ( 6-week treatment period , followed by a 6-week follow-up period ) in patients with IC/PBS . Patients were r and omized to weekly intravesical treatment with 2.0 % sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control . Primary efficacy analysis compared responders ( moderately or markedly improved ) according to the 7-point Global Response Assessment . Secondary endpoints include question naires focused on symptoms and quality of life . RESULTS Sixty-five evaluable patients were r and omized . At the primary endpoint analysis ( week 7 ) , 22.6 % of the vehicle control group were responders compared with 39.4 % of the active therapy group ( P = .15 ) . There was no statistically significant difference for any of the secondary endpoints . Overall , 76.9 % of the patients in the study reported at least 1 adverse event ; most were mild or moderate , the majority associated with the vehicle control treatment . Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group . CONCLUSION The difference in treatment effect in this small underpowered study was not statistically significant , although twice as many patients reported a clinical ly significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment . This trial provides data required to design a well-powered r and omized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy In March 2003 experts on interstitial cystitis ( IC ) from around the world met in Kyoto , Japan for a series of workshops intended to define areas of agreement and difference in the approach to this disease . This workshop explored the diagnostic criteria IC in the clinical and research setting s. The NIDDK criteria are used almost universally for research but there is tremendous disparity in the clinics and no consensus at all as to the best practice in diagnosing IC for clinical purpose s. Throughout the world many physicians use the NIDDK research criteria for clinical diagnosis ; in some countries this is st and ard . Undoubtedly , this m and ates under-diagnosis and denies treatment to many patients . Still , a majority feel that one diagnostic system is m and atory to promote clarity in communication . The group called for two initiatives to help advance this area of controversy : ( 1 ) a large-scale , prospect i ve study critically examining the role of  cystoscopy , bladder distention , and biopsy  in the diagnosis of IC ; ( 2 ) a concerted effort to develop a single evidence -based guideline or algorithm that would be flexible enough to meet the needs of clinicians , research ers , and patients Interstitial cystitis ( IC ) is a bladder syndrome of unknown etiology . The cause of IC is most likely multifactorial and includes genetic and environmental factors . Various pathophysiological changes in the bladder , pelvis , and peripheral and central nervous systems have been identified , and this has led to the emergence of biologically specific treatment modalities . Interstitial cystitis is being diagnosed with increasing frequency ; however , current diagnostic criteria are non-uniform , and there is significant overlap between chronic pelvic pain syndromes in men and women , interstitial cystitis , recurrent " cystitis , " and the overactive bladder syndrome . The diagnosis of interstitial cystitis can be made clinical ly and by cystoscopy and hydrodistension . The sensitivity and specificity of urinary markers and the potassium sensitivity test have not been prospect ively studied PURPOSE We determined the efficacy and safety of pelvic floor myofascial physical therapy compared to global therapeutic massage in women with newly symptomatic interstitial cystitis/painful bladder syndrome . MATERIAL S AND METHODS A r and omized controlled trial of 10 scheduled treatments of myofascial physical therapy vs global therapeutic massage was performed at 11 clinical centers in North America . We recruited women with interstitial cystitis/painful bladder syndrome with demonstrable pelvic floor tenderness on physical examination and a limitation of no more than 3 years ' symptom duration . The primary outcome was the proportion of responders defined as moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment scale . Secondary outcomes included ratings for pain , urgency and frequency , the O'Leary-Sant IC Symptom and Problem Index , and reports of adverse events . We compared response rates between treatment arms using the exact conditional version of the Mantel-Haenszel test to control for clustering by clinical center . For secondary efficacy outcomes cross-sectional descriptive statistics and changes from baseline were calculated . RESULTS A total of 81 women r and omized to the 2 treatment groups had similar symptoms at baseline . The global response assessment response rate was 26 % in the global therapeutic massage group and 59 % in the myofascial physical therapy group ( p=0.0012 ) . Pain , urgency and frequency ratings , and O'Leary-Sant IC Symptom and Problem Index decreased in both groups during followup , and were not significantly different between the groups . Pain was the most common adverse event , occurring at similar rates in both groups . No serious adverse events were reported . CONCLUSIONS A significantly higher proportion of women with interstitial cystitis/painful bladder syndrome responded to treatment with myofascial physical therapy than to global therapeutic massage . Myofascial physical therapy may be a beneficial therapy in women with this syndrome PURPOSE Interstitial cystitis ( IC ) is a debilitating condition which causes irritative bladder symptoms , pain and a decrease in health status . The pathophysiology is poorly understood so therapeutic options are diverse . Percutaneous posterior tibial nerve stimulation is an effective treatment and pulsed transdermal laser stimulation is an established technique for pain management . We evaluated the efficacy of transdermal laser stimulation of the posterior tibial nerve for patients with IC . MATERIAL S AND METHODS Women meeting the National Institutes of Health National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC were prospect ively recruited and r and omized to treatment ( 29 ) or placebo ( 27 ) cohorts in a double-blind trial . At home the patient performed laser therapy daily for 30 seconds over the SP6 acupuncture point for 12 weeks . Measures at baseline and at 84-day followup included the 7-day voiding diary , the Interstitial Cystitis Problem Index , Interstitial Cystitis Symptom Index and R AND 36-Item Health Survey question naires . RESULTS There were no significant differences between the treatment and control cohorts on any of the measures . However , there was a significant decrease between baseline and 12-week followup in the amount voided , symptom problems and severity , and on all 8 SF-36 scales . There was no significant effect of fluid intake . CONCLUSIONS This study demonstrated no difference between the active and sham device . However , it is interesting that treatment and control cohorts experienced similar improvements , suggesting that the control cohort improvements may have been due to participants ' belief that they were receiving active treatment from the stimulator . These findings provide support for investigating placebo effects in r and omized trials OBJECTIVES To present clinical evidence with botulinum toxin A ( BTX-A ) suggesting an antinociceptive role in patients with interstitial cystitis ( IC ) . Intriguing evidence in a somatic pain model has suggested that BTX-A injection may have an antinociceptive effect on both acute and chronic ( inflammatory ) pain . METHODS Thirteen female patients ( 6 in the United States and 7 in Pol and ) with IC according to the criteria of the National Institute of Diabetes , Digestive and Kidney Disease were included . Under short general anesthesia or sedation , 100 to 200 U of Dysport ( Polish patients ) or Botox ( U.S. patients ) was injected through a cystoscope into 20 to 30 sites submucosally in the trigone and floor of the bladder . Patients were evaluated with the O'Leary-Sant vali date d IC question naire or with voiding charts and a visual analog pain scale 1 month postoperatively and at subsequent 3-month intervals . The Polish patients also underwent pretreatment and post-treatment urodynamic evaluations . RESULTS Overall , 9 ( 69 % ) of 13 patients noted subjective improvement after BTX-A treatment . The Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index mean scores improved by 71 % and 69 % , respectively ( P < 0.05 ) . Daytime frequency , nocturia , and pain by visual analog scale decreased by 44 % , 45 % , and 79 % , respectively ( P < 0.01 ) . The first desire to void and maximal cystometric capacity increased by 58 % and 57 % , respectively ( P < 0.01 ) . CONCLUSIONS Our results suggest that BTX-A has an antinociceptive effect on bladder afferent pathways in patients with IC , producing both symptomatic and functional ( ie , urodynamic ) improvements To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome ( IC/PBlS ) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine ( PSD597 ) , and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients OBJECTIVES To test the efficacy of a new intravesical therapeutic solution in relieving urgency/frequency and pain in interstitial cystitis ( IC ) . METHODS A solution of 40,000 U heparin , 8 mL 1 % lidocaine ( 80 mg ; group 1 ) or 2 % lidocaine ( 160 mg ; group 2 ) , and 3 mL 8.4 % sodium bicarbonate was administered intravesically in patients with newly diagnosed IC with significant frequency , urgency , and pain . Using the Patient Overall Rating of Improvement of Symptoms , the response to treatment was evaluated within 20 minutes of instillation in all patients , after 24 to 48 hours in group 2 , and after three treatments per week for 2 weeks in group 2 patients who elected to receive additional instillations . Significant symptom relief was defined as 50 % or greater symptom improvement . RESULTS After one instillation , 35 ( 75 % ) of 47 patients in group 1 ( 1 % lidocaine ) and 33 ( 94 % ) of 35 in group 2 ( 2 % lidocaine ) reported significant immediate symptom relief . The difference in the response rates was statistically significant ( P < 0.01 ) . In group 2 , 50 % of the subjects experienced at least 4 hours of symptom relief from the single instillation , and 16 ( 80 % ) of 20 reported significant sustained symptom relief after 2 weeks of treatment . CONCLUSIONS Intravesical treatment with combined heparin and alkalinized lidocaine immediately reduced the pain and urgency of IC in most patients treated for newly diagnosed IC . Symptom relief lasted beyond the duration of the local anesthetic activity of lidocaine , suggesting the solution suppresses neurologic upregulation . In IC treatment , this new intravesical solution may be helpful in the interval before heparinoid therapy reaches its full effect Objectives : The aim of this study was to verify the efficacy and safety of intravesical treatment combining sodium hyaluronate ( HA ) and chondroitin sulfate ( CS ) in patients with interstitial cystitis/bladder pain syndrome ( IC/BPS ) . Methods : Between February 2010 and May 2011 , 20 consecutive women with IC/BPS were treated with intravesical instillations containing sodium HA ( 1.6 % ; 800 mg/50 ml ) and sodium CS ( 2 % ; 1 g/50 ml ) weekly for the first month , biweekly for the second month , and then monthly for at least 3 months . Before and after treatment , all patients filled in the Interstitial Cystitis Symptom Index and Problem Index ( ICSI/ICPI ) , the Patient Health Question naire 9 and the Pelvic Pain and Urgency/Frequency Patient Symptom Scale ( PUF ) . Treatment efficacy was assessed by comparing the pre- and post-treatment mean scores of the three question naires using Student ’s t test ( p value < 0.05 was considered significant ) . Results : Statistically significant mean decreases in ICSI ( from 13.0 to 9.3 ; p = 0.0003 ) , ICPI ( from 11.35 to 8.85 ; p = 0.0078 ) and PUF ( from 20.0 to 15.75 ; p = 0.0007 ) question naire scores were seen . No cases of side effects or complications were observed . The mean follow up was 5 months . Conclusions : Despite the limitations of this study , the outcomes confirmed the role of combination therapy with HA and CS as a safe and effective option for the treatment of IC/BPS . Further r and omized controlled studies with a higher number of patients and a longer follow-up period are needed to confirm these results We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain ( CPP ) , painful bladder syndrome , and interstitial cystitis ( IC ) . Thirty consecutive patients ( 21 female , 9 male ) with severe refractory symptoms underwent bilateral S2-S4 sacral neuromodulation for CPP/IC . Patients were evaluated with the O'Leary IC symptom and problem index ( ICSI , ICPI ) , the short form of the Urogenital Distress Inventory ( UDI-6 ) , and the R AND 36-item health survey ( SF-36 ) preoperatively and 6 months postoperatively . The mean and minimum follow-up were 15 and 6 months , respectively . Of the 30 patients , 23 ( 77 % ) had a successful trial stimulation and were permanently implanted . Among these patients , the ICSI and ICPI scores improved by 35 ( p = 0.005 ) and 38 % ( p = 0.007 ) , respectively . The pain score improved by 40 % ( p = 0.04 ) and the UDI-6 score by 26 % ( p = 0.05 ) . On average , patients reported a 42 % improvement in their symptoms . SF-36 scores did not improve significantly . In refractory patients , bilateral caudal epidural sacral neuromodulation is another possible mode of treatment , which appears to improve both pelvic pain and voiding symptoms Introduction and hypothesisIntravesical instillations of hyaluronic acid ( HA ) and chondroitin sulfate ( CS ) may lead to regeneration of the damaged glycosaminoglycan layer in interstitial cystitis/bladder pain syndrome ( IC/BPS ) . Methods Twenty-two patients with IC/BPS received intravesical instillations ( 40 ml ) of sodium HA 1.6 % and CS 2.0 % in 0.9 % saline solution ( IALURIL ® , IBSA ) once weekly for 8 weeks , then once every 2 weeks for the next 6 months . Results The score for urgency was reduced from 6.5 to 3.6 ( p = 0.0001 ) , with a reduction in pain scores from an average of 5.6 to 3.2 ( p = 0.0001 ) . The average urine volume increased from 129.7 to 162 ml ( p < 0.0001 ) , with a reduction in the number of voids in 24 h , from 14 to 11.6 ( p < 0.0001 ) . The IC Symptom and Problem Index decreased from 25.7 to 20.3 ( p < 0.0001 ) , and the Pain Urgency Frequency score , from 18.7 to 12.8 ( p < 0.0001 ) . Conclusion The treatment appeared to be effective and well tolerated in IC/BPS in this initial experience OBJECTIVES On the assumption that interstitial cystitis ( IC ) is the result of a defective mucous lining of the bladder epithelium , a study was carried out to investigate the activity of hyaluronic acid ( HA ) in the treatment of IC . HA is an important glycosaminoglycan ( GAG ) present in all connective tissues , including the GAG layer of the vesical mucosa . It exhibits a variety of pharmacologic properties that enhance its appeal for the therapy of IC . METHODS A total of 25 patients , with the characteristic picture of IC and refractory to other medical treatments , participated in a trial of  HA .  Patients received 40 mg of HA intravesically on a weekly basis for 4 weeks , then monthly . Response to therapy was evaluated by symptom score , voiding diaries , and visual analog scales . RESULTS An initial positive ( complete+partial ) response of 56 % at week 4 increased to 71 % by week 12 . This response was maintained until week 20 ; beyond week 24 there appears to be a moderate decrease in the effectiveness of the medication . There was no significant toxicity attributable to the presence of HA in the bladder . CONCLUSIONS The response of refractory IC patients to the intravesical administration of HA was gratifying . In the past , many therapies for IC that were initially considered promising failed the test of a controlled study . Further studies will establish the effectiveness of this particular preparation of HA in the treatment of IC AIMS Interstitial cystitis/bladder pain syndrome ( IC/BPS ) is a prevalent disorder that may contribute to bladder cancer ( BC ) . This cohort study set out to investigate the association between IC/BPS and BC by using a population -based data set . METHODS The data for this study were source d from the Taiwan National Health Insurance program . The case cohort comprised 7,562 patients with IC/BPS , and 22,686 r and omly selected subjects were used as a comparison cohort . A Cox proportional hazards regression model ( stratified by age group , geographic location , urbanization level , and the index year ) was constructed to estimate the risk of subsequent BC following a diagnosis of IC/BPS . We also ran the analysis utilizing an alternative comparison cohort composed of patients with urinary incontinence ( UI ) . RESULTS In the study sample of 30,248 patients , 96 patients ( 0.32 % ) received a diagnosis of BC during the 3-year follow-up period ; 48 ( 0.63 % of patients with IC/BPS ) were from the study cohort ; and 48 ( 0.21 % of patients without IC/BPS ) were from the comparison cohort . The incidence rate of BC was 2.12 ( 95 % CI : 1.58 - 2.78 ) per 1,000 person-years in patients with IC/BPS and 0.70 ( 95 % CI : 0.52 - 0.92 ) per 1,000 person-years in comparison patients . Cox proportional analysis revealed that the adjusted HR for BC during the 3-year follow-up period for patients with IC/BPS was 2.95 ( 95 % CI : 1.97 - 4.41 ) that of comparison subjects . When performing the analysis with the alternative UI comparison cohort , the adjusted HR for BC was 1.96 ( 95 % CI : 1.14 - 3.39 ) . CONCLUSIONS This investigation detected a novel association between BC and prior IC/BPS OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo .  Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects Background : Current medications used in the treatment of interstitial cystitis ( IC ) have limited efficacy . This prospect i ve study investigated the efficacy of multiple intravesical instillations of resiniferatoxin ( RTX ) at the concentration of 10 nM. Methods : Patients with proven IC previously treated with traditional medications for more than 6 months without clinical benefit were enrolled . They were excluded if bladder outlet obstruction or urinary tract infection was present .  Intravesical instillation of low-dose RTX ( 10 nM ) once weekly for 4 weeks was performed at the outpatient department . International Prostate Symptom Score ( IPSS ) , 5-Point Pain Scale , and Quality of Life Index ( QOL Index ) were recorded . A videourodynamic study was done at baseline and 3 months after treatment . Results : The therapeutic results and urodynamic parameters were compared between baseline and 3 months . Thirteen patients , including 10 women and 3 men , were enrolled in this study . The mean duration of IC  symptoms was 4.4 ± 2.5 years . The mean duration of active treatment was 15.3 ± 8.6 months . One female patient dropped out due to severe bladder pain after RTX instillation . Among the 12 patients who completed the study treatment , subjective assessment revealed that 2 had an excellent therapeutic result , 5 had an improved result and 5 remained unchanged from baseline . The overall satisfactory rate was 58.3 % . IPSS , 5-Point Pain Scale , and QOL Index were significantly decreased after RTX treatment . There was no significant increase in mean functional bladder capacity or change in urodynamic parameters . No serious adverse event occurred after RTX treatment . Conclusions : This study suggests that multiple intravesical instillations of RTX at the concentration of 10 nM are effective in relieving lower urinary tract symptoms in patients with refractory IC . The treatment is tolerable and suitable for use on an outpatient clinic basis PURPOSE Interstitial cystitis ( IC ) is a disorder of unknown etiology with few effective therapies . Oral bioflavonoid therapy utilizing quercetin recently proved to be clinical ly effective in men with chronic pelvic pain syndrome , a disorder with similarities to IC . We therefore tested in an open-label trial a quercetin-based supplement in patients with clinical ly proven IC . MATERIAL S AND METHODS Twenty-two patients ( 5 men and 17 women ; average age 53.1 years ) with classically documented IC received  one capsule of Cysta-Q complex ( equivalent to 500 mg of quercetin ) twice a day for 4 weeks . Symptoms were assessed before and after therapy by the IC problem and symptom indices as well as by global assessment of pain ( range 0 - 10 ) . RESULTS Two patients did not complete the study . In the remaining 20 patients , improvement was seen in all three parameters tested . After 4 weeks of treatment , the mean ( + /- SEM ) problem index improved from 11.3 + /- 0.6 to 5.1 + /- 0.7 ( p = .000001 ) , the mean symptom index improved from 11.9 + /- 0.9 to 4.5 + /- 0.5 ( p = .000001 ) , and the mean global assessment score improved from 8.2 + /- 0.4 to 3.5 + /- 0.4 ( p = .000001 ) . None of the patients experienced any negative side effects , and all but one patient had at least some improvement in every outcome measure . CONCLUSION Oral therapy with the quercetin supplement Cysta-Q was well tolerated and provided significant symptomatic improvement in patients with IC . Larger , r and omized , placebo-controlled trials appear warranted based on these preliminary open-label results PURPOSE A psychometric analysis of the University of Wisconsin Interstitial Cystitis Scale was conducted on 30 females previously enrolled in a phase II double-blind r and omized controlled trial evaluating the efficacy of six weekly intravesical instillations of TICE BCG .  The analyses were to : ( 1 ) evaluate the adequacy of the seven individual IC component items for measuring the range of patient responses ; ( 2 ) verify the 2-factor ( IC versus reference ) construct of the scale ; ( 3 ) evaluate the internal consistency and reliability of the IC items ; ( 4 ) better define the scale 's applicability and limitations ; and ( 5 ) if possible , make recommendations for improvements in the scale . MATERIAL S AND METHODS St and ard psychometric analyses were used to perform the evaluation , and included descriptive analysis of individual items , computing of item-total correlations and Cronbach 's internal consistency measures , and the application of factor and Rasch analyses . RESULTS The original 7-item IC scale was found to have ceiling effects that could limit its use in detecting small therapeutic differences . It was also found that the Pelvic item originally assigned to the reference set of items of the scale should be included as an IC item when used in a comparable IC population . After including this item into the IC scale Cronbach 's alpha was 0.84 , compared with 0.82 . CONCLUSIONS The UW-IC Scale has psychometric properties similar to other measurement instruments used in clinical research , and appears worthy of further study in well-characterized IC population s. The reference items suggest that IC patients do not indiscriminately report high values for generalized body complaints , but do so on bladder related symptoms as recorded by the IC items of the scale . Although the scale has limitations it appears applicable for use in future IC intervention clinical trials Purpose Bladder pain syndrome is a chronic disease that manifests as bladder pain , frequency , nocturia , and urgency . Gabapentin , amitriptyline , and nonsteroidal anti-inflammatory drugs are efficacious treatments for bladder pain syndrome . Here , we assessed the effect of triple therapy with these drugs in women with bladder pain syndrome . Methods Between May 2007 and May 2010 , we conducted a prospect i ve nonr and omized study on 74 patients with bladder pain syndrome . Of these patients , 38 ( 11 men and 27 women ; mean age , 55.9 years ; range , 25 to 77 years ; mean follow-up , 12.6 months ) were administered the interstitial cystitis ( IC ) symptom scales ( O'Leary-Sant Symptom Index ) and visual analog scale ( VAS ) 1 , 3 , and 6 months after treatment to assess the efficacy of triple therapy . Results The pretreatment O'Leary-Sant IC symptom score was 11.7 , and the post-treatment scores were 4.4 , 3.8 , and 4.0 at 1 , 3 , and 6 months , respectively ; the pretreatment problem index score was 10.5 , and the post-treatment scores were 3.7 , 2.7 , and 2.9 at 1 , 3 , and 6 months , respectively . The pretreatment VAS score was 6.7 , and the post-treatment scores were 1.8 , 1.5 , and 1.7 at 1 , 3 , and 6 months , respectively . The O'Leary-Sant IC symptom index and problem index and VAS scores improved considerably 1 month after treatment ( P<0.05 ) . However , the results at 1 , 3 , and 6 months after treatment were not significantly different ( P>0.05 ) . Conclusions Triple therapy was sufficiently effective in patients with bladder pain syndrome and caused no significant adverse effects . However , large-scale studies should be performed to verify our findings ABSTRACT Objective : To evaluate the relationship between symptom reduction and satisfaction with pentosan polysulfate sodium ( PPS ) therapy in subjects with interstitial cystitis ( IC ) . Methods : A secondary analysis was conducted in 128 subjects treated with PPS 300 mg/day ( US Food and Drug Administration-approved dose ) from a 32-week multicenter , r and omized , double-blind study of 380 subjects with IC who were treated with PPS 300 mg/day , 600 mg/day , or 900 mg/day .  Self-rated outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and a treatment satisfaction question naire . Treatment responders were defined as subjects having ≥30 % reduction in ICSI from baseline to study end point . Results : A reduction in IC symptoms was associated with significantly higher satisfaction with PPS ( p < 0.05 ) . Compared with nonresponders , subjects achieving a ≥30 % reduction in ICSI were more likely to be pleased with PPS for IC symptoms , to have benefited from PPS for their IC symptoms , to recommend PPS for IC symptoms to others with the same condition , and to say that PPS provides better relief , based on prior experience with other IC treatments . Among all subjects at week 32 , 75 % said they would recommend PPS therapy for IC symptoms to others with the condition . Conclusion : Despite limitations ( lack of placebo control , use of a nonvali date d instrument ) , this analysis demonstrated significantly increased treatment satisfaction with PPS therapy among treatment responders versus nonresponders . There was a significant positive correlation between ICSI scores and response on the treatment satisfaction question naire . Treatment response and patient satisfaction with treatment are important clinical considerations in the management of patients with IC Objective . To evaluate changes in bladder capacity and potassium sensitivity after glycosaminoglycan ( GAG ) substitution therapy . Material and methods . The study population comprised two groups of female patients with bladder pain syndrome/interstitial cystitis ( BPS/IC ) : responders ( those with symptom improvement ) and non-responders ( those without symptom improvement ) after a 10-week period of intravesical , episodic , weekly , GAG substitution therapy . A total of 27 volunteers with increased pre-therapeutic potassium sensitivity were enrolled in the study and re-evaluated using the modified comparative potassium test ( maximal bladder capacity with a saline solution versus a 0.2 M KCl solution ) following intravesical GAG substitution therapy . Results . In the 13 responders , the average maximal bladder capacity increased by 17 % with the saline solution and by 101.5 % with the 0.2 M KCl solution . In the 14 non-responders , post-therapeutic average maximal bladder capacity was decreased by 35 % with the saline solution and remained relatively unchanged after instillation with a 0.2 M KCl solution . Conclusion . These data demonstrate that in patients who respond symptomatically to intravesical GAG substitution therapy , cystometric bladder capacity is increased , whereas non-responders experience a decrease in bladder capacity To report a multicentre , community based open‐label study design ed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis ( IC ) .  Chondroitin sulphate is a naturally occurring glycosaminoglycan ( GAG ) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC , and small single‐centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC REFERENCE : Bleakley C , McDonough S , MacAuley D. The use of ice in the treatment of acute soft-tissue injury : a systematic review of r and omized controlled trials . Am J Sport Med . 2004 ; 32:251 - 261 . CLINICAL QUESTION : What is the clinical evidence base for cryotherapy use ? DATA SOURCES : Studies were identified by using a computer-based literature search on a total of 8 data bases : MEDLINE , Proquest , ISI Web of Science , Cumulative Index to Nursing and Allied Health ( CINAHL ) on Ovid , Allied and Complementary Medicine Data base ( AMED ) on Ovid , Cochrane Data base of Systematic Review s , Cochrane Data base of Abstract s of Review s of Effectiveness , and Cochrane Controlled Trials Register ( Central ) . This was supplemented with citation tracking of relevant primary and review articles . Search terms included surgery , orthopaedics , sports injury , soft tissue injury , sprains and strains , contusions , athletic injury , acute , compression , cryotherapy , ice , RICE , and cold . STUDY SELECTION : To be included in the review , each study had to fulfill the following conditions : be a r and omized , controlled trial of human subjects ; be published in English as a full paper ; include patients recovering from acute soft tissue or orthopaedic surgical interventions who received cryotherapy in inpatient , outpatient , or home-based treatment , in isolation or in combination with placebo or other therapies  ; provide comparisons with no treatment , placebo , a different mode or protocol of cryotherapy , or other physiotherapeutic interventions ; and have outcome measures that included function ( subjective or objective ) , pain , swelling , or range of motion . DATA EXTRACTION : The study population , interventions , outcomes , follow-up , and reported results of the assessed trials were extracted and tabulated . The primary outcome measures were pain , swelling , and range of motion . Only 2 groups reported adequate data for return to normal function . All eligible articles were rated for method ologic quality using the PEDro scale . The PEDro scale is a checklist that examines the believability ( internal validity ) and the interpretability of trial quality . The 11-item checklist yields a maximum score of 10 if all criteria are satisfied . The intraclass correlation coefficient and kappa values are similar to those reported for 3 other frequently used quality scales ( Chalmers Scale , Jadad Scale , and Maastricht List ) . Two review ers grade d the articles , a method that has been reported to be more reliable than one evaluator . MAIN RESULTS : Specific search criteria identified 55 articles for review , of which 22 were eligible r and omized , controlled clinical trials . The articles ' scores on the PEDro scale were low , ranging from 1 to 5 , with an average score of 3.4 . Five studies provided adequate information on the subjects ' baseline data , and only 3 studies concealed allocation during subject recruitment . No studies blinded their therapist 's administration of therapy , and just 1 study blinded subjects . Only 1 study included an intention-to-treat analysis . The average number of subjects in the studies was 66.7 ; however , only 1 group undertook a power analysis . The types of injuries varied widely ( eg , acute or surgical ) . No authors investigated subjects with muscle contusions or strains , and only 5 groups studied subjects with acute ligament sprains . The remaining 17 groups examined patients recovering from operative procedures ( anterior cruciate ligament repair , knee arthroscopy , lateral retinacular release , total knee and hip arthroplasties , and carpal tunnel release ) . Additionally , the mode of cryotherapy varied widely , as did the duration and frequency of cryotherapy application . The time period when cryotherapy was applied after injury ranged from immediately after injury to 1 to 3 days postinjury . Adequate information on the actual surface temperature of the cooling device was not provided in the selected studies . Most authors recorded outcome variables over short periods ( 1 week ) , with the longest reporting follow-ups of pain , swelling , and range of motion recorded at 4 weeks postinjury . Data in that study were insufficient to calculate effect size . Nine studies did not provide data of the key outcome measures , so individual study effect estimates could not be calculated . A total of 12 treatment comparisons were made . Ice submersion with simultaneous exercises was significantly more effective than heat and contrast therapy plus simultaneous exercises at reducing swelling .  Ice was reported to be no different from ice and low-frequency or high-frequency electric stimulation in effect on swelling , pain , and range of motion .  Ice alone seemed to be more effective than applying no form of cryotherapy after minor knee surgery in terms of pain , but no differences were reported for range of motion and girth . Continuous cryotherapy was associated with a significantly greater decrease in pain and wrist circumference after surgery than intermittent cryotherapy . Evidence was marginal that a single simultaneous treatment with ice and compression is no more effective than no  cryotherapy  after an ankle sprain . The authors reported ice to be no more effective than rehabilitation only with regard to pain , swelling , and range of motion .  Ice and compression seemed to be significantly more effective than ice alone in terms of decreasing pain . Additionally , ice , compression , and a placebo injection reduced pain more than a placebo injection alone . Lastly , in 8 studies , there seemed to be little difference in the effectiveness of ice and compression  compared with  compression alone . Only 2 of the 8 groups reported significant differences in favor of ice and compression . CONCLUSIONS : Based on the available evidence , cryotherapy seems to be effective in decreasing pain . In comparison with other rehabilitation techniques , the efficacy of cryotherapy has been question ed . The exact effect of cryotherapy on more frequently treated acute injuries ( eg , muscle strains and contusions ) has not been fully eluci date d. Additionally , the low method ologic quality of the available evidence is of concern . Many more high- quality studies are required to create evidence -based guidelines on the use of cryotherapy . These must focus on developing modes , duration s , and frequencies of ice application that will optimize outcomes after injury Objective : To determine the safety and tolerability of intravesical resiniferatoxin ( RTX ) in interstitial cystitis ( IC ) patients . Material s and Methods : IC patients were instilled with 50 cc of test solution containing either placebo , 0.05 μM or 0.10 μM RTX in the bladder . Plasma concentration of RTX and its degradant resiniferonol 9- , 13- , 14-orthophenylacetate was measured . Immediate post-treatment blood sampling and cystoscopy were performed . Symptoms were evaluated before treatment , at 4- and at 12-week follow-ups , using VAS indicator for pain , voiding diary , and O’Leary ’s IC symptom/problem indices . Results : Among 22 patients observed ( ten in 0.10 μM RTX , eight in 0.05 μM RTX , and four in placebo groups ) , the most commonly reported adverse event was pain during instillation ( 80.0 % , 87.5 % , and 25.0 % ) . No serious adverse events were reported . Conclusions : Use of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 μM and 0.05 PURPOSE We have conducted a prospect i ve open-label study to examine the safety and efficacy of the long-term administration of the tricyclic antidepressant amitriptyline in patients with interstitial cystitis ( IC ) . METHODS Patients were stratified into 2 groups : an NIDDK group including patients fulfilling the NIDDK criteria for IC and a non-NIDDK group encompassing patients who presented the characteristic IC symptoms but met at least one of the NIDDK exclusion criteria .  Amitriptyline was taken strictly at bedtime following an established self-titration protocol without a limitation of the maximum daily dosage . Patients reporting improvement in a global response assessment question naire were defined as treatment responders . Further efficacy measures included changes of pain and urgency , functional bladder capacity and frequency . Changes in the O'Leary-Sant IC index and rating of overall satisfaction with the therapeutic outcome are reported as well . RESULTS The mean follow-up of the study was 19.0 + /- 12.5 months . The response rate was 64 % ( 60 patients ) . Overall mean dosage was 55 mg ( range : 12.5 - 150 mg ) . Side effects occurred in 79 patients ( 84 % ) ( dry mouth : 79 % , weight gain : 59 % ) . Patient overall satisfaction with the therapeutic result was either excellent or good in 43 patients ( 46 % ) . The drop-out rate was 31 % ( 29 patients ) after a mean treatment period of 6 weeks at a mean dosage of 70 mg . Non-response to treatment was the primary reason for drop-out in all cases , side effects contributed to drop-out in 25 patients ( 86 % ) . The various IC symptoms improved statistically significant compared with baseline . CONCLUSIONS Long-term administration of amitriptyline is a feasible , safe and effective treatment for IC provided that the drug is used judiciously to minimise adverse effects . The therapeutic response to amitriptyline was uniformly observed in patients fulfilling the NIDDK criteria and in those patients with the pure clinical diagnosis of IC PURPOSE Increased urothelial permeability has been proposed as a cause of interstitial cystitis ( IC ) . The potassium sensitivity test assesses bladder discomfort after instillation of 0.4 M KCl for identification of increased urothelial permeability . Since exposure to 0.4 M KCl may be extremely painful for patients with IC we investigated a less traumatic alternative . MATERIAL S AND METHODS The study comprised 38 controls and 40 patients with IC . In all subjects cystometry was performed with 0.9 % NaCl followed by 0.2 M KCl , and filling volume at first urge and maximum bladder capacity ( Cmax ) were assessed for both solutions . RESULTS Controls did not show a significant change in Cmax . KCl decreased Cmax in 37 of 40 ( 92 % ) patients with IC with a mean decrease of 30 % . The examination was painless in all controls and in 33 of 40 ( 82 % ) patients with IC , and was moderately painful in 7 . CONCLUSIONS For demonstration of increased potassium sensitivity and diagnosis of IC , comparative assessment of Cmax is a well tolerated alternative to the 0.4 M potassium sensitivity test . Statistical evaluation of these results suggests that a decrease in Cmax greater than 30 % is indicative of IC INTRODUCTION AND OBJECTIVES According to National Institute of Health ( NIH ) criteria , a bladder capacity of less than 350 cc is an automatic exclusion for a diagnosis of Interstitial Cystitis ( IC ) . In the present study , patients , showing symptoms of IC and with bladder capacities of < 350 and > /=350 cc were tested as to their response to a intravesical hyaluronic acid therapy . METHODS The study included 48 patients with clinical symptoms of IC and a positive 0.4 M potassium sensitivity test .  Maximum bladder capacity ( C(max ) ) was assessed for the 0.9 % NaCl solution first and then for the 0.2 M KCl solution . After the NaCl cystometry , patients were separated into two groups : Group I with a C(max ) of < 350 cc and Group II with a C(max ) of > /=350 cc . Both groups were again separated in two further groups as to the respective percentage reduction of C(max ) with the 0.2 M KCl solution : Group Ia/IIa ( > /=30 % ) and Group Ib/IIb ( < 30 % ) . Patients were treated with weekly instillations of 40 mg hyaluronic acid for 10 consecutive weeks . Pre- and post-treatment bladder symptoms were evaluated through their visual analog scale ( VAS ) scores . RESULTS With the saline solution , 32 patients had a C(max ) of < 350 cc ( Group I ) , while 16 patients had a C(max ) of > /=350 cc ( Group II ) . Evaluation of VAS scores confirmed a positive response , i.e. symptom relief , to hyaluronic acid therapy , irrespective of bladder capacity . The improvement was particularly evident in patients with a C(max ) reduction of > /=30 % versus those with a reduction of < 30 % with the 0.2 M KCl solution ( p=0.003 ) . CONCLUSION The present study demonstrates that patients with typical IC symptoms and a cystometric bladder capacity of > /=350 cc , may have increased potassium sensitivity as a sign of IC and show symptom improvement after hyaluronic acid instillation therapy Objectives To determine , in a double‐blind placebo‐controlled crossover study , whether l‐arginine improves the symptoms of interstitial cystitis ( IC ) , a chronic condition in which nitric oxide ( NO ) may be important , as previous open pilot studies suggested that l‐arginine reduced the pain and frequency associated with IC Interstitial cystitis ( IC ) is a disorder of the urinary bladder characterized by urgency , frequency , nocturia and suprapubic pain . IC occurs primarily in women and symptoms are exacerbated by stress , ovulatory hormones and certain foods . IC pathogenesis is unknown , but the most consistent findings involve some dysfunction of the bladder glycosaminoglycan ( GAG ) protective layer and a high number of activated bladder mast cells . There is no effective therapy even through intravesical administration of dimethylsulfoxide ( DMSO ) or oral pentosanpolysulfate ( PPS ) have had variable success . A dietary supplement , CystoProtek ® , was formulated with the natural GAG components chondroitin sulfate and sodium hyaluronate to provide urothelial cytoprotection , together with the flavonoid quercetin that has anti-inflammatory properties and inhibits activation of mast cells . Thirty-seven female patients diagnosed by the NIDDK criteria who had failed all forms of therapy  took six softgel CystoProtek ® capsules per day for 6 months . Global assessment scale was reduced from 9.0 ± 2.9 to 4.3 ± 2.1 ( p < 0.05 ) ; moreover , the O'Leary/Sant Symptom Index decreased from 16.3 ± 3.1 to 6.9 ± 4.2 ( p < 0.05 ) and the Problem Index from 13.1 ± 3.7 to 5.4 ± 4.0 ( p < 0.05 ) . These results are very promising and warrant a larger study that may permit further analyses with respect to other , especially atopic , comorbid diseases OBJECTIVES Interstitial cystitis ( IC ) is a chronic , debilitating condition that is often associated with late diagnosis and a delay in initiation of appropriate IC-specific therapy . The purpose of this study was to determine whether the length of time from initial diagnosis to start of treatment impacts subsequent symptom improvement . METHODS A retrospective analysis was conducted in 128 patients with IC who had been treated with pentosan polysulfate sodium ( PPS ) 300 mg/day for 32 weeks in a multicenter , r and omized , double-blind , parallel-group clinical trial . Outcome measures included the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) and the O'Leary-Sant Interstitial Cystitis Problem Index ( ICPI ) . Early treatment was defined as treatment initiation 6 months or less after IC diagnosis , whereas late treatment was defined as treatment initiation 24 months or more after IC diagnosis . Efficacy data were analyzed by using the intent-to-treat , last-observation-carried-forward population . RESULTS At the end of the study , mean changes from baseline in total ICSI and ICPI scores ( + /- SEM ) for early treatment ( 6 months or less ) versus late treatment ( 24 months or more ) were 3.97 + /- 0.59 versus 2.15 + /- 0.70 ( P = 0.0472 ) and 3.94 + /- 0.56 versus 1.77 + /- 0.63 ( P = 0.0117 ) , respectively . Similar trends for both measures were observed when examining other times from IC diagnosis ( 3 months or less versus 24 months or more , 3 months or less versus 36 months or more , and 6 months or less versus 36 months or more ) . CONCLUSIONS Initiation of PPS treatment within 6 months of establishing the diagnosis of IC may be associated with greater improvement in patient symptoms and symptom bother ( 1 ) Chondroitin sulfate solution 2.0 % is a glycosaminoglycan ( GAG ) replenishment therapy instilled into the bladder of GAG-deficient patients with interstitial cystitis ( IC ) . ( 2 ) Two non-r and omized , uncontrolled pilot studies report improvements in patient-reported symptoms after the use of chondroitin sulfate for one year . Prospect i ve , r and omized , head-to-head trials are needed to assess the effectiveness of this technology compared with other IC therapies . ( 3 ) The cost and dem and for this technology are low , but there could be a significant impact on clinics that administer treatment , if uptake increases OBJECTIVES To evaluate the efficacy of intravesical instillation of hyaluronic acid ( HA ) after hydrodistention for the treatment of patients with interstitial cystitis ( IC ) having small bladder capacity . METHODS A total of 47 patients with IC ( aged 27 - 76 years ) whose functional bladder capacity was less than 200 mL received bladder hydrodistention .  Thereafter , 20 patients received intravesical instillation of 40 mg HA weekly in the first month and then monthly in the following 2 months . Sixteen patients received intravesical heparin instead and 11 patients received hydrodistention alone as the control . Mean voids per day , visual analog scale for pain , and functional bladder capacity were measured before hydrodistention and 3 and 6 months after hydrodistention in all 3 groups and 9 months after hydrodistention in HA and heparin groups . RESULTS Two patients in the HA group and 1 in the heparin group failed to complete the treatment . Three months after hydrodistention , there was no improvement in the control group . Six and 9 months after hydrodistention , rate of improvement was significantly higher in the HA group than in the heparin group ( 77.8 % vs 33.3 % , P < .05 ; 50 % vs 20 % , P < .05 ) . At 9 months , heparin treatment did not show any improvement . Improvement in voids per day ( -1.8 + /- 2.5 , P < .01 ) , visual analog scale ( -0.9 + /- 1.1 , P < .01 ) , and bladder capacity ( 16 + /- 18 mL , P < .01 ) was still significant in the HA group . CONCLUSIONS Intravesical instillation of HA may obviously prolong the effect of bladder hydrodistention in patients with severe IC . Its effect was better than heparin PURPOSE This pilot study was design ed to evaluate the feasibility of a multicenter , r and omized , clinical trial in interstitial cystitis ( IC ) . Secondary objectives were to evaluate the safety and efficacy of oral pentosan polysulfate sodium ( PPS ) , hydroxyzine , and the combination to consider their use in a larger r and omized clinical trial . MATERIAL S AND METHODS A 2 x 2 factorial study design was used to evaluate PPS and hydroxyzine .  Participants met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency for a minimum of 6 months before study entry . The primary end point was a patient reported global response assessment . Secondary end points included vali date d symptom indexes and patient reports of pain , urgency and frequency . The target sample size was 136 participants recruited during 10 months . RESULTS A total of 121 ( 89 % of goal ) participants were r and omized over 18 months and 79 % provided complete followup data . The response rate for hydroxyzine was 31 % for those treated and 20 % for those not treated ( p = 0.26 ) . A nonsignificant trend was seen in the PPS treatment groups ( 34 % ) as compared to no PPS ( 18 % , p = 0.064 ) . There were no treatment differences for any of the secondary end points . Adverse events were mostly minor and similar to those in previous reports . CONCLUSIONS The low global response rates for PPS and hydroxyzine suggest that neither provided benefit for the majority of patients with IC . This trial demonstrated the feasibility of conducting a multicenter r and omized clinical trial in IC using uniform procedures and outcomes . However , slow recruitment underscored the difficulties of evaluating commonly available IC drugs OBJECTIVES To determine the usefulness of oral hydroxyzine for the treatment of  symptomatic interstitial cystitis .  METHODS This study was an open-label , nonconsecutive case series of patients treated by their local physicians , in consultation with the authors . A case-report form using visual analog scales was used to assess outcomes . RESULTS Out of 140 patients , 90 ( 65 % ) returned the case-report forms . A 40 % reduction in symptom scores was reported . This rose to 55 % in patients with a history of allergies . CONCLUSIONS Hydroxyzine is a useful drug for the symptomatic treatment of IC , especially in patients with documented allergies and /or evidence of bladder mast cell activation To provide evidence for the clinical efficacy of changes in urinary pH on the pain associated with interstitial cystitis ( IC ) PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive The O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) has been proposed as a treatment outcome measure in interstitial cystitis ( IC ) . The psychometric properties of the ICSI were assessed for reliability and validity in a r and omized , double-blind clinical study of 300 , 600 , and 900 mg daily dose of pentosan polysulfate sodium ( PPS ) in patients with IC . The ICSI contains 4 items that measure urgency and frequency of urination , nighttime urination , and pain or burning . The ICSI index score is the sum of the item scores ( range : 0 - 20 ) . ICSI scores were obtained at baseline , 4 , 8 , 12 , 16 , 24 , and 32 weeks of treatment . Patients ' overall ratings of improvement of symptoms ( PORIS ) scores evaluating improvements in pain , urgency , and overall IC symptoms were also collected except at baseline . A total of 376 patients were included in the analysis . Psychometric properties evaluated included variability ( range ) , test-retest reliability ( intraclass correlation coefficient [ ICC ] ) , internal consistency ( the Cronbach alpha ) , construct validity ( convergent , discriminant ) , responsiveness , and clinical ly meaningful change . The ICSI items and index score had good variability and test-retest reliability . The ICSI demonstrated internal consistency reliability and was responsive to change . Participants indicating a 75 % improvement in PORIS had a 48 % mean reduction in the ICSI score , while participants reporting 100 % improvement in PORIS had a 77 % mean reduction in the ICSI score . The ICSI is a valid , reliable , and responsive measure of change in IC symptoms . This outcome measure should be utilized in future treatment outcomes studies in IC OBJECTIVES To compare the current recommended dose of pentosan polysulfate sodium ( PPS ) with doses two to three times higher . METHODS We evaluated three dosages ( 300 , 600 , and 900 mg ) of PPS in a r and omized , double-blind , double-dummy , parallel-group , multicenter , 32-week study . Adults ( n = 380 ) with a diagnosis of interstitial cystitis ( IC ) as determined by a positive cystoscopic examination combined with bladder pain and urgency or a history of IC symptoms for at least 6 months were enrolled . Participants completed the Patient 's Overall Rating of Symptom Index ( PORIS ) and the O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) at baseline ( ICSI only ) and during follow-up visits at 4 , 8 , 12 , 16 , 24 , and 32 weeks . RESULTS Mean ICSI scores improved significantly during the 32 weeks for all dosages ( baseline 11.2 , 11.9 , and 11.9 to endpoint 8.2 , 8.1 , 8.6 for 300 , 600 , and 900 mg , respectively ; P < 0.001 ) but the response to treatment was not dose dependent ( no statistically significant difference in response among the three dosages ) . At baseline , 3.2 % , 62.2 % , and 34.6 % reported mild , moderate , and severe symptoms , respectively , as assessed by the ICSI . At study end , 27.5 % , 56.9 % , and 15.7 % reported mild , moderate , and severe symptoms , respectively . The PORIS scores improved within 4 weeks with 15.8 % to 21.1 % of all patients classified as responders ( 50 % or greater improvement on PORIS ) . At 32 weeks , 49.6 % , 49.6 % , and 45.2 % of all patients were responders at a dose of 300 , 600 , and 900 mg , respectively . Most adverse events were mild and resolved without intervention . CONCLUSIONS For all three dosages of PPS , a clinical ly significant but similar response was demonstrated . The duration of therapy appears to be more important than the dosage INTRODUCTION The aim of this study was to examine the efficacy and safety of intravesical Bacillus Calmette-Guerin ( BCG ) in the treatment of refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Thirteen patients with refractory IC were enrolled in the study . They were scheduled to receive 6 weekly courses of treatment with intravesical BCG . Variables including the frequency , nocturia , urgency , pelvic pain , dyspareunia , dysuria , IC symptom index , IC problem index , and average voided volume were assessed every 6 months after the BCG therapy . RESULTS Thirteen patients received the complete course of intravesical BCG therapy . Twenty-four months after the treatment a mean improvement of 51.9 % was seen in frequency ( P=.001 ) , 43.2 % in nocturia ( P=.002 ) , 28.7 % in urgency ( P=.004 ) , 43.1 % in pelvic pain ( P=.001 ) , 58.3 % in dyspareunia ( P=.003 ) , 6.5 % in dysuria ( P=.16 ) , 57.7 % in the O'Leary-Sant IC symptom index ( P=.001 ) , and 61.8 % in the O'Leary-Sant IC problem index ( P=.001 ) scores . A significant improvement was seen in the mean average voided volume at the 24th follow-up month ( 89.5 % ; P=.001 ) . CONCLUSION Intravesical BCG is a relatively effective treatment in patients with refractory IC . Its efficacy seems to be modest and lasts for at least 24 months in majority of the patients . It is also safe and well tolerated OBJECTIVES An oral preparation of pentosanpolysulfate sodium ( PPS ) was recently approved by the Food and Drug Administration for interstitial cystitis ( IC ) . Previously published articles have documented improvement in symptoms in 28 % to 63 % of patients , but no long-term studies have been published . No unique characteristics except for Hunner 's ulcer have been found in patients experiencing relief from PPS . We report our experience with PPS  following patients up to 116 months and analyze baseline parameters in an attempt to characterize long-term responders . METHODS Baseline and follow-up data from 97 patients with IC and enrolled in a compassionate use study with PPS at the University of Wisconsin from 1987 to 1995 are analyzed . Previous treatments had failed , and patients had to pay for PPS . Patients continuing treatment with PPS were monitored every 3 months with question naires and laboratory tests . In 1996 an up date on medication and a question naire developed by the National Institutes of Health Interstitial Cystitis Data base were sent to patients who had discontinued treatment . RESULTS By the end of the study period 11 ( 11.3 % ) of the patients were still taking PPS , with 6 ( 6.2 % ) doing so continuously for more than 18 months . Three ( 3 % ) patients who discontinued PPS were in long-term remission . An additional 15 % had remission for a substantial period . Except for a weak correlation between less constant pain ( P = 0.0439 ) , no correlations were found between baseline parameters and duration of treatment with PPS . CONCLUSIONS On a long-term basis , between 6.2 % and 18.7 % of patients with IC benefit from PPS . The only baseline factor predicting response to PPS was less constant pain Background Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk . We evaluated a goal - setting intervention aim ed at promoting increased cognitive and physical activity and improving mental and physical fitness , diet and health . Methods This was a pilot r and omised controlled trial design ed to guide planning for a larger-scale investigation , provide preliminary evidence regarding efficacy , and explore feasibility and acceptability . Primary outcomes were engagement in physical and cognitive activity .  Participants aged over 50 living independently in the community were recruited through a community Agewell Centre . Following baseline assessment participants were r and omly allocated to one of three conditions : control ( IC ) had an interview in which information about activities and health was discussed ; goal - setting ( GS n = 24 ) had an interview in which they set behaviour change goals relating to physical , cognitive and social activity , health and nutrition ; and goal - setting with mentoring ( GM , n = 24 ) had the goal - setting interview followed by bi-monthly telephone mentoring . Participants and research ers were blinded to group assignment . Participants were reassessed after 12 months . Results Seventy-five participants were r and omised ( IC n = 27 , GS n = 24 , GM n = 24 ) . At 12-month follow-up , the two goal - setting groups , taken together ( GS n = 21 , GM n = 22 ) , increased their level of physical ( effect size 0.37 ) and cognitive ( effect size 0.15 ) activity relative to controls ( IC n = 27 ) . In secondary outcomes , the two goal - setting groups taken together achieved additional benefits compared to control ( effect sizes ≥ 0.2 ) in memory , executive function , cholesterol level , aerobic capacity , flexibility , balance , grip strength , and agility . Adding follow-up mentoring produced further benefits compared to goal - setting alone ( effect sizes ≥ 0.2 ) in physical activity , body composition , global cognition and memory , but not in other domains . Implementation of the recruitment procedure , assessment and intervention was found to be feasible and the approach taken was acceptable to participants , with no adverse effects . Conclusions A brief , low-cost goal - setting intervention is feasible and acceptable , and has the potential to achieve increased activity engagement . Trial registration Current Controlled Trials IS RCT PURPOSE Interstitial cystitis ( IC ) is a clinical condition occurring predominantly in women that is characterized by irritative voiding symptoms , including urinary frequency , urgency and pain . To our knowledge its etiology is unknown and little is known about its occurrence . We evaluated the prevalence of  IC in women in Finl and . MATERIAL S AND METHODS A total of 2,000 participants were r and omly selected from the Finnish population register . Urinary symptoms were evaluated using the vali date d O'Leary-Sant IC symptom and problem index question naire . Women with moderate or severe symptom scores ( 7 or higher ) without any urinary tract infection during the last month were invited to undergo clinical examination . RESULTS Of the 1,331 respondents 32 had moderate or severe symptoms involving a suspicion of IC , of whom 21 underwent clinical evaluation . Three women were found to have probable IC and 4 had possible IC . Thus , the prevalence of clinical ly confirmed probable IC in women was 230/100.000 ( 95 % CI 100 to 360 ) and that of possible/probable IC was 530/100.000 ( 95 % CI 140 to 910 ) . Considering the lack of information on 8 patients with urinary symptoms the corrected estimates were 300/100,000 ( 95 % CI 120 to 770 ) and 680/100,000 women ( 95 % CI 360 to 1,300 ) , respectively . CONCLUSIONS Our results based on a large and representative population , and clinical ly confirmed diagnoses indicate that IC is substantially more common than previously thought BACKGROUND AND OBJECTIVE Periodontitis may alter the systemic condition in patients with diabetes and hence interfere with glycemic control . The objective of this study was to determine the quantifiable changes in glycated hemoglobin ( HbA1C ) after periodontal non-surgical therapy plus azithromycin in a mixed population of patients with poorly controlled diabetes . MATERIAL S AND METHODS One hundred and five patients were r and omized to receive non-surgical therapy plus azythromycin ( AZ-Sca = 33 ) , non-surgical therapy plus placebo ( PB-Sca = 37 ) and supragingival prophylaxis plus azithromycin ( AZ-Pro = 35 ) . Glycated hemoglobin , glycemia and periodontal parameters were measured at baseline , 3 , 6 and 9 mo after treatment . RESULTS Periodontal parameters were improved in the AZ-Sca and PB-Sca groups as compared to the AZ-Pro group . A greater reduction in probing depth was observed in the AZ-Sca as compared to the PB-Sca group . Improvement in clinical attachment level was similar between AZ-Sca and PB-Sca groups . A reduction from 8.0 % to 7.2 % ( ∆0.8 % ; p < 0.05 ) in HbA1C was observed in the AZ-Sca at 9 mo as compared to the PB-Sca group in which the reduction was from 7.9 % to 7.6 % ( ∆0.3 % ) . There was no decrease in HbA1C in the AZ-Pro group over time . Mean glycemia values decreased from 195 mg/dL to 159.2 mg/dL ( ∆35.8 mg/dL ; p < 0.05 ) in the AZ-Sca group whereas a decrease from 194 mg/dL to 174.8 mg/dL ( ∆19.2 mg/dL ) in the PB-Sca group at 9 mo was observed . There were no differences between the AZ-Sca and PB-Sca groups for glycemic parameters . No improvement in glycemic values in the AZ-Pro group was observed . CONCLUSIONS A modest improvement in glycemic control was detected with a trend towards the use of non-surgical therapy plus AZ as compared to the placebo Background Cryotherapy ( the application of ice for therapeutic purpose s ) is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury . Despite its widespread clinical use , the precise physiological responses to therapeutic cooling have not been fully eluci date d , and effective evidence -based treatment protocol s are yet to be established . Intermittent ice applications are thought to exert a significant analgesic effect . This could facilitate earlier therapeutic exercise after injury , potentially allowing for a quicker return to activity . The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain . Methods / Design The study is a r and omised controlled trial . 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic . Subjects will be r and omised under strict double-blind conditions to either a st and ard cryotherapy ( intermittent ice applications with compression ) or cryokinetic treatment group ( intermittent ice applications with compression and therapeutic exercise ) . After the first week , treatment will be st and ardised across groups . Assessor blinding will be maintained throughout the trial . Primary outcome will be function , assessed using the Lower Extremity Functional Scale ( LEFS ) . Additional outcomes will include pain ( 10 cm Visual Analogue Scale ) , swelling ( modified figure-of-eight method ) and activity levels ( activ PAL ™ physical activity monitor , PAL Technologies , Glasgow , UK ) . Diagnostic Ultrasound ( Episcan-1 - 200 high frequency ultrasound scanning system , Longport International Ltd , PA ) will also be used to assess the degree of soft tissue injury . After baseline assessment subjects will be followed up at 1 , 2 , 3 & 4 weeks post injury . All data will be analysed using repeated measures analysis of co-variance ( ANCOVA ) . Discussion This paper describes the rationale and design of a r and omised controlled trial which will examine the effectiveness of two different cryotherapy protocol s in the early management of acute ankle sprain . Trial Registration IS RCT OBJECTIVE To establish the efficacy of a multidrug oral treatment with the tricyclic antidepressant agent doxepin and the cyclooxygenase ( COX ) inhibitor piroxicam in patients with interstitial cystitis ( IC ) , who had failed st and ard therapy in an open , prospect i ve , nonr and omized study . METHODS A total of 37 patients diagnosed with IC received 75 mg doxepin and 40 mg piroxicam daily . The treatment was termed DOXCAM .  Effectiveness of therapy was assessed with frequency-volume charts , an IC symptom score and with cystometry prior to treatment , 8 weeks after the start and 4 weeks after termination of drug treatment . RESULTS Medication was not tolerated by five patients . Twenty-six of 32 patients have experienced virtual total remission of symptoms ( 81 % ) and six patients had significant relief ( 19 % ) . DOXCAM treatment result ed in a significant percent decrease in pain ( 65 % versus 21 % ) . Daytime frequency decreased from 17.6+/-5.7 to 11.3+/-3.6 voids while nocturia did not improve significantly . Twenty-three of the 26 patients who became symptom free and four of the six patients who showed significant improvement had a return of symptoms after cessation of therapy . CONCLUSION It is reasonable to consider oral treatment with DOXCAM in those patients who have failed first-line therapies The TORCH ( Towards a Revolution in COPD Health ) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease . These include collection of off-treatment exacerbation data , analysis of exacerbation rates and the effect of inclusion of patients receiving inhaled corticosteroids ( ICS ) prior to r and omisation . When effective medications are available to patients who withdraw , inclusion of off-treatment data can mask important treatment effects on exacerbation rates . Analysis of on-treatment data avoids this bias but it needs to be combined with careful analysis of withdrawal patterns across treatments . The negative binomial model is currently the best approach to statistical analysis of exacerbation rates , while analysis of time to exacerbation can supplement this approach . In the TORCH trial , exacerbation rates were higher among patients with previous use of ICS compared to those with no prior use on all study treatments . Retrospective subgroup analysis suggests  ICS reduced exacerbation rates compared with placebo , regardless of prior use of ICS before entry to the study . Factorial analysis provides an alternative analysis for trials with combinations of treatments , but assumes no interaction between treatments , an assumption which can not be verified by a significance test . No definitive conclusions can yet be drawn on whether ICS treatment has an effect on mortality INTRODUCTION It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency , frequency , and pain associated with interstitial cystitis ( IC ) . This combination has also been reported to relieve pain associated with sex in patients with IC . AIM The aim of this study was to corroborate these findings in a multicenter setting . METHODS The study design was a multicenter prospect i ve , double-blind , crossover , placebo-controlled trial . Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria ( excluding cystoscopy ) for IC . Each patient received drug and control , in r and om order , within 48 hours of enrolling in the study . MAIN OUTCOME MEASURES The primary outcome measure was percent change in pain score ( 11-point analog pain scale ) 12 hours after receiving the drug or control . Secondary measures were the global assessment response ( GAR ) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales . RESULTS Eighteen ( 18 ) patients completed the trial . The average reduction of pain over 12 hours was 21 % for control and 42 % for active drug ( P = 0.0363 ) . GAR was 13 % for control and 50 % for drug ( P = 0.0137 ) . Average urgency reduction was 13 % for control and 35 % for drug ( P = 0.0328 ) . CONCLUSIONS The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC . This combination provides significant immediate relief of symptoms for patients with IC OBJECTIVES To compare the efficacy of a 4-week ofloxacin-containing regimen and the st and ard WHO-MDT regimen for PB leprosy , in terms of the rate and timing of relapse after treatment completion . DESIGN 124 PB patients were enrolled in a r and omised , double-blind trial . Of these , 66 received the st and ard 6-month WHO-MDT regimen , whereas 58 received 28 daily supervised doses of rifampicin 600 mg + ofloxacin 400 mg , plus 5 months of placebo . Patients were regularly monitored for clinical response and for signs of relapse after treatment completion . RESULTS Patients enrolled in the ofloxacin  group had a mean follow-up of 10.8 years ( 628 patient-years ) with 1 early relapse at 3 years after treatment completion . On relapse , this patient remained smear negative but was reclassified by current WHO criteria ( > or = 6 skin lesions ) as multibacillary ( MB ) . Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years ( 749 patient-years ) with two late relapses at 8 and 12 years , both still classified as PB on relapse . CONCLUSION In conclusion , both regimens appeared generally efficacious , and , in particular , result ed in few relapses PURPOSE We report an observational study to evaluate the efficacy and tolerability of duloxetine for interstitial cystitis . MATERIAL S AND METHODS A total of 48 women were prospect ively treated for 2 months following an uptitration protocol to the target dose of 2 x 40 mg duloxetine per day . Patients received the target dose for 5 weeks . The efficacy of duloxetine treatment was assessed at week 8 . The primary end point was a change in the overall well-being evaluated by a patient reported global response assessment . Secondary end points were changes in pain and urgency ( visual analog scales ) , frequency and functional bladder capacity ( 48-hour voiding log ) , and changes in overall symptom severity ( O'Leary-Sant index ) . RESULTS There were 5 patients ( 10.4 % ) who were identified as responders and 17 patients ( 35.4 % ) who dropped out of the study exclusively due to side effects , with nausea present in all dropouts . No severe adverse events were reported . All 5 responders reported onset of symptom improvement but not until they had reached the target dose . Regarding secondary outcome parameters , duloxetine treatment did not result in statistically significant improvement of symptoms . Maximum urinary flow rate and residual volume were influenced more prominently in patients at the target dose , however , the changes did not appear to be clinical ly meaningful . CONCLUSIONS Treatment of interstitial cystitis with duloxetine did not result in significant improvement of symptoms . The drug administration was safe but the tolerability of the drug was poor mainly due to nausea occurring with the starting dose of 20 mg per day . Based on the preliminary data of this observational trial we currently can not recommend duloxetine as a therapeutic approach for interstitial cystitis BACKGROUND Sequential therapy ( ST ) seems to offer higher success rates than triple therapy ( TT ) in the eradication of Helicobacter pylori ( H. pylori ) infection . However , from the st and point of therapeutic compliance , there is no difference between the two treatments . Adjuvant treatment ( especially with probiotics ( PB ) and lactoferrin ( LF ) ) has often improved compliance and eradication rates in patients subjected to TT , while ST had never been used in association with adjuvants . METHODS Over a period of 2 years , we r and omized and divided 227 consecutive adult patients with H. pylori infection into three groups . The patients were given ST with the addition of adjuvants , as follows : group A ( ST + placebo ) , group B ( ST + LF + PB ) , and group C ( ST + PB ) . Our goal was to assess therapeutic compliance , so we prepared a question naire to help determine the severity of the side effects . We also determined the eradication rates for the groups . RESULTS Patients with ST + placebo had the worst compliance as compared with the other two groups in terms of the absence of symptoms ( p < .001 between B and A ; p = .001 between C and A ) and the presence of intolerable symptoms ( p = .016 between B and A ; p = .046 between C and A ) . The differences between the values for the treated groups and those for the placebo group were statistically significant . On the other h and , there was no statistically significant difference in compliance between groups B and C. The eradication rate was similar for the three groups . CONCLUSIONS Probiotics associated with ST provide optimum therapeutic compliance compared with the placebo and , despite the need to take a larger number of tablets , they should be taken into consideration as an adjuvant to therapy for H. pylori infection . The addition of LF to the PB did not bring about any further improvements in compliance . As compared with the placebo , the eradication rate of ST did not improve by adding LF + PB or by using PB alone
Meta- analysis of RCTs showed that only cyclosporine A provided a simultaneous great effect size of SMD on ICSI , pain , and frequency .
Amitriptyline at different dosages showed a great effect size of SMD on pain and urgency or on ICSI and frequency .
The results from the n RCTs showed that the most frequently adopted treatment is oral pentosan polysulfate and that the use of botulinum A toxin intradetrusorial injections in PBS/IC is increasing .
Limited evidence exists for the few treatments for PBS/IC .
The lack of definitive conclusions is due to the great heterogeneity in methodology , symptoms assessment , duration of treatment , and follow-up in both RCTs and n RCTs
CONTEXT Different types of behavioural , dietary , interventional , pharmacologic , and surgical therapies have been used to treat painful bladder syndrome/interstitial cystitis ( PBS/IC ) .
Because of the paucity of r and omised placebo-controlled studies on different treatments , an evidence -based management approach has not yet been developed .
OBJECTIVE To critically review and synthesize data from a wide range of current therapeutic approaches to PBS/IC , to quantify the effect size from r and omised controlled trials ( RCTs ) , and to reach clinical agreement on the efficacy of treatments for PBS/IC .