Phosphodiesterase inhibitors in the treatment of erectile dysfunction in spinal cord-injured men Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury Efficacy and safety of tadalafil in men with erectile dysfunction following spinal cord injury. A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose,Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction Vardenafil Improves Ejaculation Success Rates and Self-confidence in Men With Erectile Dysfunction due to Spinal Cord Injury Sildenafil efficacy in erectile dysfunction secondary to spinal cord injury depends on the level of cord injuries. Up-titration of vardena fi l dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury. Efficacy, safety and predictive factors of therapeutic success with sildenafil for erectile dysfunction in patients with different spinal cord injuries Quality of life in patients with spinal cord injury receiving VIAGRA® (sildenafil citrate) for the treatment of erectile dysfunction
Study design : Open , before – after study . Objective : To assess the efficacy and safety of phosphodiesterase type 5 ( PDE5 ) inhibitors for erectile dysfunction ( ED ) in spinal cord-injured ( SCI ) patients . Setting : Home- and clinic-based assessment s in the outpatient department at the Centre Bouffard Vercelli , Cerbère France . Methods : Clinic trials with Sildenafil ( Viagra ® )  on 120 patients , Tadalafil ( Cialis ® ) on 54 patients and Vardenafil ( Levitra ® ) on 66 patients were performed . Flexible doses of PDE5 inhibitors were given depending on efficacy and tolerability , from 50 to 100 mg for Sildenafil , and from 10 to 20 mg for Vardenafil and Tadalafil . Each trial was performed after a week 's interval . The efficacy was self-assessed by the patients on a six-point quantitative scale assessment . The response to treatment was assessed at home in 90 patients ( 57 patients on Sildenafil , 12 patients on Vardenafil and 21 patients on Tadalafil )  using the International Index of Erectile Function ( IIEF ) . Results : In clinic trials , PDE5 inhibitors were effective ( rigidity enough for penetration ) in 85 % of the patients on Sildenafil , 74 % of the patients on Vardenafil and 72 % of the patients on Tadalafil .  The mean duration of erection was 34 , 28 and 26 min , respectively . Adverse effects were mild , usually attenuated with continued dosing . More than 70 % of the patients on Vardenafil and Tadalafil required higher doses of 20 mg , whereas 50 mg of Sildenafil was effective in 55 % of the patients . Two-thirds of our patients on Tadalafil reported a duration of action longer than 24 h. The presence of an upper motor neuron lesion was significantly associated with therapeutic success , lower motor neuron lesions and cauda equina patients were poor responders . Other variables such as completeness of lesion had no impact . In the follow-up visits , the IIEF global scores and three IIEF domains ( erectile function , intercourse satisfaction and overall satisfaction ) were significantly improved in all patients . Patients on Sildenafil showed a significant improvement of orgasmic function , ejaculation ( Question 9 ) and orgasm ( Question 10 ) . Conclusion : Sildenafil , Vardenafil and Tadalafil are all effective and well-tolerated treatments for ED in SCI patients . Although no statistical analysis could be applied on these data , these results might indicate that Sildenafil is more effective in treating ED . Clinic trials are important for proper dose titration and appropriate education of the patients Objective : To assess the efficacy and tolerability of vardenafil in men with erectile dysfunction ( ED ) due to traumatic spinal cord injury ( SCI ) . Methods : In this multicenter , double-blind , placebo-controlled , parallel-group 12-week study , 418 men aged 18 years and older with ED for more than 6 months consequent to SCI were r and omized to vardenafil ( n = 207 ) or placebo ( n = 211 ) ( 10 mg for 4 weeks , then maintained or titrated to 5 or 20 mg at weeks 4 and 8) . Efficacy assessment s included the erectile function ( EF ) domain score of the International Index of Erectile Function question naire and diary questions regarding penetration , maintenance of erection to completion of intercourse , and ejaculation . Results : Baseline patient characteristics were similar in the vardenafil ( mean age 40 years ) and placebo ( mean age 39 years ) groups . Mean baseline EF domain scores were 11.6 in the vardenafil group and 12.1 ( moderate ED ) in the placebo group . EF domain score in the vardenafil group improved to 22.0 ( mild ED ) at last observation carried forward vs 13.5 in the placebo group ( p < 0.001 ) . Over 12 weeks of treatment , mean per-patient penetration ( 76 % vs 41 % ) , maintenance ( 59 % vs 22 % ) , and ejaculation ( 19 % vs 10 % ) success rates were significantly greater vs placebo ( all p < 0.001 ) . The most frequently reported drug-related adverse events were headache ( vardenafil 15 % , placebo 4 % ) , flushing ( vardenafil 6 % , placebo 0 % ) , nasal congestion ( vardenafil 5 % , placebo 0 % ) , and dyspepsia ( vardenafil 4 % , placebo 0 % ) . Conclusion : Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury OBJECTIVE To determine the efficacy and safety of tadalafil when taken on dem and by men with erectile dysfunction ( ED ) secondary to traumatic spinal cord injury ( SCI ) . DESIGN AND SETTING Multicenter , r and omized , double-blind , placebo-controlled , flexible dose-titration , parallel-group study in clinical practice s in Europe . Patients Enrolled patients had ED secondary to SCI ( all spinal levels ) and sustained 6 months or longer before visit 1 . INTERVENTIONS After a 4-week run-in period , patients were r and omly assigned to tadalafil , 10 mg , ( n = 142 ) or placebo  ( n = 44 ) for a 12-week , on-dem and treatment period with assessment s at 4-week intervals . The dose of tadalafil was maintained or titrated ( 10 or 20 mg ) at 4 and 8 weeks . MAIN OUTCOME MEASURES Efficacy was measured using the International Index of Erectile Function ( IIEF ) , Sexual Encounter Profile ( SEP ) , and Global Assessment Question ( GAQ ) . Treatment-emergent adverse events and vital signs were collected at each visit . RESULTS Mean age was 38 years .  Mean baseline IIEF erectile function domain score was 13.4 , and following 12 weeks of treatment , 22.6 for tadalafil and 13.6 for placebo ( P < .001 ) . After treatment , the tadalafil group compared with the placebo group was significantly greater ( P < .001 ) in mean per-patient percentage of successful penetration attempts ( SEP question 2 ; 75.4 % vs 41.1 % ) and intercourse attempts ( SEP question 3 ; 47.6 % vs 16.8 % ) ; percentage of improved erections ( GAQ question 1 ; 84.6 % vs 19.5 % ) ; and ejaculatory frequency ( IIEF question 9 ; P = .03 ) . The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache ( 8.5 % vs 4.5 % ) and urinary tract infection ( 7.7 % vs 6.8 % ) . CONCLUSIONS Tadalafil ( 10 mg and 20 mg ) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI Abstract Background / objective : To show the efficacy , safety , and tolerability of sildenafil in men with erectile dysfunction ( ED ) associated with complete or incomplete spinal cord injury ( SCI ) and to assess its effects on quality of life ( Qol ) using the Life-Satisfaction Check List . Methods : This was a placebo-controlled , multicenter , r and omized , double-blind , flexible-dose , 2-way crossover study with a 2-week washout period between each phase . Patients with ED attributable to SCI(Sexual Health Inventory-Male score ≤21 ) received 50 to 100 mg sildenafil ( n = 24 ) or placebo ( n = 26 ) . Results : Compared with placebo , sildenafil produced higher levels of successful sexual stimulation , intercourse success , satisfaction with sexual life and sexual relationship , erectile function , overall sexual satisfaction , and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score , with no clinical ly relevant effects onvital signs . Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI , producing significant improvements , compared with placebo , in a number of measures only in patients with incomplete SCI . All patients who expressed a preference selected sildenafil over placebo , although the drug had no effect on patient Qol .  Sildenafil was well tolerated , with a profile comparable to that of placebo . Conclusions : Compared with placebo , treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI , especially in those with incomplete injury , and was theagent of choice in those who expressed a preference Study Design . Multicenter , double-blind , placebo-controlled , parallel-group study . Objective . To assess the effect of the oral phosphodiesterase type-5 inhibitor , vardenafil , on ejaculation rates and self-confidence in men with spinal cord injury ( SCI ) . Summary of Background Data . Spinal comm and of male sexual functions is often seriously impaired by traumatic spinal cord injury ( SCI ) . A high proportion of men with SCI can not ejaculate during sexual intercourse . SCI-related ejaculatory disorders are often responsible for male infertility . Sexual dysfunction associated with SCI can also affect men 's self-confidence . Methods . In this 12-week study , 418 men aged ≥18 years with erectile dysfunction > 6 months result ing from a traumatic SCI were r and omized to vardenafil ( n = 207 ) or placebo ( n = 211 ) 10 mg for 4 weeks , then maintained or titrated to 5 or 20 mg at weeks 4 and 8 . Assessment s included questions of the International Index of Erectile Function ( IIEF ) about ejaculation success and orgasmic perception ; the Global Confidence Question ; and quality -of-life scales to measure psychological well-being , self-esteem , depression , and mental health status . Results . Overall per patient ejaculation success rates were significantly greater with vardenafil than placebo over 12 weeks of treatment ( 19 % vs. 10 % ; P < 0.001 ) . At last observation carried forward , the IIEF “ orgasmic function ” score increased from 2.9 at baseline to 4.0 for vardenafil and from 3.0 at baseline to 3.4 for placebo . Sixteen percent of men receiving vardenafil and 8 % receiving placebo felt orgasm “ almost always ” or “ always ” at weeks 8–12 , compared with 4 % and 6 % , respectively , at baseline . Significant improvements in confidence scores were observed with vardenafil compared with placebo ( P < 0.0001 ) . There were no clinical ly significant differences between vardenafil and placebo in the quality -of-life measures at the study endpoint , but these had been in the normal range at baseline . Conclusion . Vardenafil significantly improved ejaculation and self-confidence in men with erectile dysfunction due to SCI To evaluate the efficacy of sildenafil in the treatment of neurogenic erectile dysfunction ( ED ) secondary to upper motor neuron ( UMN ) and lower motor neuron ( LMN ) spinal cord injury ( SCI ) . After taking consents 105 patients suffering from ED were enrolled in this prospect i ve study . Seventy-two patients had signs and symptoms of UMN and 33 patients had signs and symptoms of LMN or mixed ( UMN and LMN ) spinal cord injuries . The patients took 50 - 100 mg sildenafil or placebo tablet at least 45 min before sexual intercourse . Based on a IIEF question naire , success in achieving erection adequate for sexual intercourse was compared between sildenafil and placebo groups in UMN and non-UMN spinal cord injuries . In patients with UMN disease , sildenafil was effective in 82 % of patients and its efficacy was statistically higher than placebo ( 82 vs. 25 % , p < 0.05 ) . Twenty-eight per cent of patients with non-UMN disease had a favourable response to sildenafil that was not statistically different from placebo . Sildenafil seems more effective in the treatment of  neurogenic ED secondary to UMN spinal cord injury compared with that secondary to LMN injury . Actually , its efficacy on LMN injuries does not seem different from placebo and administration of this treatment may not be effective in spinal cord injury which has caused LMN symptoms AIM Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction ( ED ) . Efficacy of vardenafil has been demonstrated in various ED population s , but that in Japanese patients with spinal cord injury ( SCI ) has not been assessed . METHODS This was an open-label , multicenter , flexible dose , 12-week study in patients with ED due to SCI . Following a 4-week observation period , patients received vardenafil 10 mg for 4 weeks , and based on efficacy , tolerability and patient preference , doses for the remaining 8 weeks were decided by investigators . The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function . RESULTS Ten patients took 10 mg all through the study , while 22 patients took 20 mg after completing 4 weeks ' treatment with 10 mg . The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward ( LOCF ) in the former group and from 10.3 to 22.5 in the latter group , respectively . Importantly , there was a 5.0 point increase in erectile function domain score after up-titration in the latter group . Drug-related adverse events were observed in 22 % of patients including hot flushes ( 9 % ) and headache ( 6 % ) , but these were transient and mild in intensity . Serious adverse events and adverse events leading to discontinuation of the study drug were not reported . CONCLUSIONS Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI . Of interest , erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg Study design : Multicenter , open , prospect i ve , before-after study . Objective : To assess the efficacy and safety of sildenafil therapy for erectile dysfunction in patients with spinal cord injury , and the association between the response to sildenafil and factors such as causes and levels of spinal cord injury , grade of ASIA deficit , time since injury , orgasmic perception , and degree of baseline erection . Setting : Homes of out patients of 16 spinal cord injury units in Spain . Method : One hundred and seventy patients with erectile dysfunction secondary to spinal cord injury , from whom baseline data were collected on their sexual function , and who started treatment with sildenafil 50 mg .  An efficacy assessment was made by the patient and his partner , and the score of the International Index of Erectile Function ( IIEF ) was recorded . Results : It was reported by 88.2 % of the patients and 85.3 % of their partners that treatment with sildenafil had improved their erections , regardless of the baseline characteristics of the spinal cord injury and erectile function . In responders , this improvement was confirmed by an increase from 12.5 to 24.8 points ( P<0.001 ) of the Erectile Function Domain of IIEF . A significant improvement was also seen in patients ' satisfaction with sexual activity and general satisfaction derived from sexual life . Preservation of orgasmic perception and a baseline degree of erection of 3 or 4 ( P=0.006 ) were predictors of therapeutic success . No serious adverse events occurred . Conclusion : Sildenafil is an effective , well-tolerated treatment for erectile dysfunction caused by spinal cord injury , regardless of the cause , neurological level , ASIA grade , and time since injury . Sponsorship : Spanish Society of Paraplegia . Spinal Cord ( 2001 ) 39 , 637–643 Study design : A multicenter , r and omized , double-blind , placebo-controlled , flexible-dose , two-way crossover study conducted June 1996 through January 1997 . Objectives : To evaluate the effect of sildenafil citrate ( VIAGRA ® ) on the quality of life ( QoL ) of men with erectile dysfunction ( ED ) caused by spinal cord injury ( SCI ) . Setting : Study centers in Australia , Belgium , France , Germany , Norway , Sweden and the United Kingdom . Methods : Questions 13 and 14 of the 15-item International Index of Erectile Function ( IIEF ) addressed QoL issues directly related to ED in 178 men with SCI . A 5-item question naire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments , including the Medical Outcomes Survey ( MOS ) Short Form-12 , Psychological General Well-Being Index , and MOS Family Survey , assessed general QoL issues . Results : Significant improvements were seen for overall satisfaction with sex life ( IIEF Q13 ) , sexual relationship with partner ( IIEF Q14 ) , and concerns about erectile problems ( P<0.0001 ) . Improvements were reported in scores for the generic QoL parameters of mental health , well-being , depression , and anxiety ( P<0.05 sildenafil versus placebo ) . Conclusion : Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.Sponsorship : This study was funded by Pfizer
Conclusions : This systematic review and meta- analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo , as measured by response to GEQ , SEP2 , SEP3 and incidence of adverse events .
PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI
Study design : Systemic review Objective : We carried out a systematic review and meta- analysis to assess the efficacy and safety of phosphodieterase-5 ( PDE5 ) inhibitors on erectile dysfunction ( ED ) secondary to spinal cord injury ( SCI ) .