Effects of Macroplastique Implantation System for stress urinary incontinence and urethral hypermobility in women. Long-term follow-up comparison of durasphere and contigen in the treatment of stress urinary incontinence. Where should bulking agents for female urodynamic stress incontinence be injected? Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere. Randomized controlled multisite trial of injected bulking agents for women with intrinsic sphincter deficiency: mid-urethral injection of Zuidex via the Implacer versus proximal urethral injection of Contigen cystoscopically.
A study was carried out to evaluate efficacy of Macroplastique(R) (MPQ) Implantation System (MIS) in women with urodynamic stress urinary incontinence (SUI) and urethral hypermobility after an unsuccessful conservative treatment. This is a prospective randomized controlled trial in women without previous incontinence surgery. Twenty-four women received MPQ. Twenty-one controls underwent a pelvic floor muscle exercises home program. Follow-up was at 3 months and the MPQ group also at 12 months. At 3 months, pad usage decreased significantly more in the MPQ group than in the control group (p = 0.015). According to physician and patient self-assessment, respectively, 71% and 63% women in the MPQ group were considered cured or markedly improved. This was significantly higher compared to controls. There was a significant higher increase of Incontinence Quality-of-Life questionnaire score in the MPQ group compared to controls (p = 0.017). Improvements in MPQ group at 3 months are sustained to 12 months. Adverse events were mild and transient. MIS is an acceptable option for women with SUI and urethral hypermobility. OBJECTIVES.: This study evaluates the long-term clinical success of Durasphere (Carbon Metal Technologies, St. Paul, MN) compared with Contigen (C. R. Bard, Covington, GA) in the treatment of stress urinary incontinence caused by intrinsic sphincter deficiency (ISD). METHODS.: Fifty-two women diagnosed with stress urinary incontinence caused by ISD were treated between March and November of 1998 in a randomized, double-blinded trial comparing Durasphere and Contigen. Pad testing, Stamey Continence Grading, and urodynamics, including abdominal leak point pressures, were performed during the initial evaluation. All patients were diagnosed with ISD and displayed abdominal leak point pressures of </= 90 cm of H2O. RESULTS.: Of 26 patients in each group, 25/26 (96%) Durasphere patients and 21/26 (81%) Contigen patients were available for this follow-up of 2.6 and 2.8 years, respectively, post initial injection. A total of 80% of Durasphere patients and 62% of Contigen patients demonstrated an improvement of >/=1 continence grade at this follow-up. Of these patients, 10/25 (40%) Durasphere patients and 3/21 (14%) Contigen patients are dry. CONCLUSIONS.: Long-term follow-up demonstrated that Durasphere had greater success than Contigen in providing improved continence grades. For bulking agents used for female stress urinary incontinence, the recommendation for the anatomical placement varies as some injectables are to be placed close to the bladder neck and others midurethrally. Aim of the study was to determine if there are differences concerning the outcome after transurethral collagen injections depending on the anatomical placement midurethrally or at the bladder neck. We randomly assigned 30 elderly female patients with urodynamic stress incontinence to either transurethral collagen injection midurethrally or to the bladder neck. Prior to injection and at ten month follow-up, maximum urethral closure pressure (MUCP), functional urethral length (FUL), maximum flow rate and cough test were performed and the patient was asked to estimate her bladder condition using a visual analogue scale. Postoperative contentness was 8 (median, 95% confidence interval 5-9) in the midurethral group and 8 (median, 95% confidence interval 7-10) in the bladder neck group with a p value of 0.012, 95% confidence interval -2.464 to -0.2859, in favour to midurethral injections. MUCP and FUL increased significantly in both groups and flow rate decreased in both groups. Continence was 66.6% in the midurethral group and 60% for the bladder neck group respectively. Both midurethral and bladder neck collagen injections improve patients' satisfaction almost equally with a small advantage for midurethral injections. We evaluated the effectiveness of periurethral autologous fat injection as treatment for female stress urinary incontinence.
                Women with stress incontinence were randomized in a double-blind fashion to receive periurethral injections of autologous fat (treatment group) or saline (placebo group). After injection patients were evaluated monthly for 3 months by a validated standardized incontinence questionnaire, 1-hour pad test and cough test. Patients who remained incontinent were offered repeat injection using the same initial agent to a maximum of 3 injections. Every 3 months after injection patients were assessed by a standardized questionnaire, pad test, cough test and urodynamics. Those who did not qualify for repeat injection at 3 months were then followed 6, 9, 12, 18 and 24 months or until failure.
                Of the 68 women enrolled 35 received fat and 33 received saline injections. The groups were comparable in terms of baseline parameters. A total of 56 patients completed the study, including 27 in the fat and 29 in the placebo group, for a total of 189 injections (91 fat and 98 saline). At 3 months 6 of 27 (22.2%) and 6 of 29 (20.7%) women were cured or improved in the fat and saline groups, respectively. Complications included cystitis in 9 of 189 injections, urinary retention in 6 in the fat injection group, urge incontinence in 9 of 68 patients and pulmonary fat embolism resulting in death in 1 of 189 procedures.
                In this study periurethral fat injection did not appear to be more efficacious than placebo for treating stress incontinence. To assess the safety and effectiveness of Durasphere compared with bovine collagen in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
                This multicenter, randomized, controlled, double-blind trial was composed of 355 women diagnosed with SUI due to ISD and used a standardized pad test and the Stamey continence grade as the primary endpoints. The participants' ages ranged from 26 to 84 years. All patients had an abdominal leak point pressure of less than 90 cm H(2)O (average 51).
                At 12 months after the first injection, the two materials were equivalent with respect to the improvement in continence grade and pad weight testing. Less Durasphere was injected to obtain comparable clinical results (Durasphere 4.83 mL versus bovine collagen 6.23 mL, P <0.001). When examined 1 year after the date of the last treatment, 49 (80.3%) of the 61 women treated with Durasphere showed improvement of 1 continence grade or more compared with 47 (69.1%) of 68 women treated with bovine collagen (P value for difference = 0.162). Although the adverse events reported for both groups were similar, the Durasphere group had an increased short-term risk of urgency and urinary retention.
                The use of Durasphere for the treatment of SUI due to ISD was equally effective as bovine collagen and used less material. The U.S. Food and Drug Administration granted market approval for Durasphere on September 13, 1999. The product design and initial clinical data suggest the potential for greater durability of the clinical benefit, with the possibility of a permanent solution for SUI due to ISD in some patients. To determine whether Zuidex using a non-cystoscopy mid-urethral injection technique produces as good a result (i.e. was not inferior) as Contigen injected endoscopically at the bladder neck in the treatment of urinary stress incontinence secondary to intrinsic sphincter deficiency in adult women.
                A prospective 2:1 randomized trial of mid-urethral injections of Zuidex-Implacer vs proximal urethral cystoscopic injections of Contigen was performed in 344 women with intrinsic sphincter deficiency at 23 North American sites, and followed up for >1 year from last treatment.
                Outcomes at 12 months from last treatment failed to demonstrate that mid-urethral injected Zuidex was equivalent to cystoscopically injected Contigen in primary and secondary outcome variables. The primary outcome, the proportion of women who achieved a 50% reduction in urinary leakage on provocation testing, was achieved in 84% of Contigen-treated women vs 65% of Zuidex-treated women.
                Confounding multiple variables inherent in the study design make a detailed analysis of study outcomes difficult.