Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. Genuine stress incontinence: prospective randomized comparison of two operative methods. Randomized prospective comparison of needle colposuspension versus endopelvic fascia plication for potential stress incontinence prophylaxis in women undergoing vaginal reconstruction for stage III or IV pelvic organ prolapse. The Continence Program for Women Research Group. Surgical strategies for women with pelvic organ prolapse and urinary stress incontinence. A randomized trial of burch retropubic urethropexy and anterior colporrhaphy for stress urinary incontinence. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. A randomized comparison of Burch colposuspension and abdominal paravaginal defect repair for female stress urinary incontinence.
To compare the Burch colposuspension and the anterior colporrhaphy in women with both stress urinary incontinence and advanced anterior vaginal wall prolapse (cystocele).
                Prospective randomised study.
                Secondary referral centre, Urogynaecology Unit, San Gerardo Hospital, Monza, Italy.
                Seventy-one women undergoing surgery for primary genuine stress incontinence and concurrent grade 2 or 3 cystocele (descending at or outside the vaginal introitus).
                Full urodynamic investigation performed pre-operatively and repeated six months after surgery. Clinical follow up continued for 8 to 17 years.
                Subjective (patient history) and objective (negative stress test result) cure of stress incontinence. Assessment of cystocele recurrence.
                Thirty (86%) of the 35 evaluable women who had the Burch colposuspension and 17 (52%) of the 33 evaluable women who had the anterior colporrhaphy were subjectively cured (OR 5.6, 95% CI 1.6 to 21.6; P = 0.005). Objective cure rates were 74% (26 of 35) and 42% (14 of 33), respectively (OR 3.9, 95% CI 1.3 to 12.5; P = 0.02). A recurrent cystocele of grade 2 or 3 with or without prolapse at other vaginal sites was recorded in 34% (12 of 35) and 3% (1 of 33) of women, respectively (OR 16.7, 95% CI 2.0 to 368.1; P = 0.003).
                The Burch colposuspension was better in controlling stress incontinence but it lead to an unacceptable high rate of prolapse recurrence. The anterior colporrhaphy was more effective in restoring vaginal anatomy but it was accompanied by an unacceptable low cure rate of stress incontinence. Neither of the two operations is recommended for women who are suffering from a combination of stress incontinence and advanced cystocele. The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
                In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
                Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.
                As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.). Eighty-one women with clinical and urodynamic findings of genuine stress incontinence and genital prolapse were randomly selected to be surgically treated with either anterior colporrhaphy or Burch colposuspension. Each patient had a complete clinical and urodynamic evaluation before surgery and at 2 months and 3 years after surgery. Differences in cure rates between the two procedures at the 2-month post-operative evaluation were insignificant; however, at the 3-year post-surgical evaluation, the cure rate of women who had undergone Burch colposuspension was significantly higher than that of women who had undergone anterior colporrhaphy (cure rates were 88% and 57%, respectively; P < 0.001). The Burch colposuspension was more effective than the anterior colporrhaphy in the stabilization of the bladder base, neck and proximal urethra as confirmed by transvaginal sonography. Post-operative spontaneous voiding was uneventful in both procedures. Results of this study demonstrate that the Burch colposuspension in our hands was more effective in treating genuine stress incontinence and pelvic relaxation than was anterior colporrhaphy. Severe prolapse may mask potential genuine stress urinary incontinence in women. Some have suggested that a suspending urethropexy be performed in women who have potential genuine stress incontinence demonstrated by barrier reduction of the prolapse preoperatively. Our aim was to compare outcomes after prolapse surgery that included a formal bladder neck suspension with those operations that did not.
                This prospective randomized clinical trial assigned 32 women with bladder neck hypermobility and stage III or IV pelvic organ prolapse to receive either a needle colposuspension or bladder neck endopelvic fascia plication as part of the vaginal reconstructive surgery. Twenty-nine subjects underwent detailed clinical, anatomic, urodynamic, and quality-of-life evaluations before and 6 weeks and 6 months after surgery; 23 completed urinary diary and quality-of-life evaluations after a mean of 2.9 years.
                Needle colposuspension increased short-term complications without providing additional protection from de novo stress incontinence. Barrier testing before surgery predicted urethral sphincteric resistance after surgery; however, such testing neither predicted a patient's function after surgery nor indicated the need for a suspending urethropexy. The combination of a needle colposuspension with a sacrospinous ligament suspension predisposed to the early development of support defects of the upper anterior vaginal segment and to failure of bladder neck support.
                Preoperative barrier testing in women with severe prolapse is not useful in identifying individuals who require a suspending urethropexy. Needle colposuspension increases short-term complications, lacks durability, and may predispose to early and severe recurrent anterior prolapse when performed with a sacrospinous ligament vault suspension. This study aims to compare the result of an incontinence procedure performed at the time of prolapse repair or 3 months later in women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
                In a multicenter prospective randomized trial, women with POP and SUI were randomized to have a tension-free vaginal tape (TVT) at the time of prolapse repair (n = 87; group I) or 3 months later (n = 94; group II). Women in group II were evaluated for SUI 3 months after the prolapse repair. Those with confirmed SUI had a TVT performed (n = 53). The main evaluation of all women was 1 year after the last surgery.
                On-treatment analysis resulted in 95% cure of SUI in group I and 89% in group II (p = 0.12). Twenty-seven percent were cured after prolapse surgery alone.
                No differences were found between the two treatment strategies, but almost one third of women were cured of SUI by prolapse surgery alone. In a randomized trial, we compared the success of Burch retropubic urethropexy to the modified anterior colporrhaphy for the treatment of genuine stress urinary incontinence.
                Thirty-five patients with stress incontinence were randomly assigned to undergo Burch retropubic urethropexy or modified anterior colporrhaphy. Subjects had preoperative and 1-year postoperative physical examinations, multichannel urodynamic testing, 20-minute pad test, and subjective grading of incontinence severity with questionnaires. Data were evaluated using Fisher exact test, Wilcoxon two-sample test, logistic regression analysis, and analysis of variance.
                Objective cure 1 year postoperatively was significantly greater for the women treated by Burch retropubic urethropexy than by modified anterior colporrhaphy (16 of 18 [89%] versus five of 16 [31%], relative risk .15, 95% confidence interval .04, .59). Patients' subjective ratings of incontinence severity 1 year after surgical treatment were significantly lower in women who had Burch retropubic urethropexy.
                Burch retropubic urethropexy yields a significantly superior objective cure for genuine stress urinary incontinence than the modified anterior colporrhaphy in a randomized trial. To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta(®) anterior).
                Randomised, controlled trial.
                Three teaching hospitals.
                Women with a symptomatic cystocele at least stage II requiring primary surgical correction.
                A total of 125 women were assessed at baseline and 1-year follow up. A sacrospinous hysteropexy or posterior colporrhaphy was performed when indicated.
                The primary outcome was the difference in anatomical cure (defined as Pelvic Organ Prolapse-Quantification <stage II cystocele). Secondary outcomes were complications, self-reported urogenital symptom severity, and quality of life, as measured with validated questionnaires.
                In all, 64 women were allocated to the anterior colporrhaphy group and 61 to the mesh group; 58/64 women versus 56/61 completed 12 months of follow-up analysis. Compared with the anterior colporrhaphy group, the mesh reduced the risk of anatomical failure at 12 months follow up from 59 to 9% (risk reduction 50.3%, 95% CI 35.5-65.1). Only three (5%) re-operations for anatomical failure in the anterior colporrhaphy group were performed versus 0% in the mesh group. Functional outcome improved significantly at 12 months on almost all domains, with similar results between groups. Mesh exposure occurred in two (4%) women. Baseline dyspareunia disappeared significantly more often after an anterior colporrhaphy (80%) than in the mesh group (20%). There was a trend towards more de novo dyspareunia in the mesh group (15% versus 9%).
                Primary cystocele repair with trocar-guided transobturator mesh resulted in a statistically significant better anatomical outcome compared with the anterior colporrhaphy. However, functional outcome was similar between groups.
                © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG. To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy.
                Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.
                Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group.
                Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups. Our aim was to compare Burch colposuspension and paravaginal repair for success rates, complications, and urodynamic effects when the procedures are used in the treatment of stress urinary incontinence.
                Thirty-six patients were enrolled. A full urodynamic evaluation was repeated 6 months postoperatively.
                Twelve (67%) and 17 (94%) subjects (Burch colposuspension vs paravaginal repair) voided spontaneously before discharge (p = 0.04). One patient receiving the Burch procedure underwent urethral dilation for urinary retention. Follow-up was for 1 to 3 years. Differences in subjective and objective cure rates favored the Burch colposuspension over the paravaginal repair: 100% versus 72% (p = 0.02) and 100% versus 61% (p = 0.004), respectively. The paravaginal repair did not produce significant modifications in profilometry. Postoperatively, cotton swab tests had negative results in all patients with the Burch operation and in 33% of those with the paravaginal repair (p = 0.01).
                Paravaginal repair is not recommended for the treatment of stress incontinence, although it was accompanied by a more immediate resumption of voiding.
There were not enough data to allow comparison of anterior vaginal repair with physical therapy or needle suspension for primary urinary stress incontinence in women. Open abdominal retropubic suspension appeared to be better than anterior vaginal repair judged on subjective cure rates in eight trials, even in women who had prolapse in addition to stress incontinence (six trials). The need for repeat incontinence surgery was also less after the abdominal operation. However, there was not enough information about post-operative complications and morbidity.