Randomized controlled trial comparing single-incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results.

BACKGROUND: The role of single-incision mini-slings (SIMS) in stress urinary incontinence (SUI) management is still not elucidated. OBJECTIVE: To compare efficacy and safety of SIMS and transobturator sling (TOT) for SUI after 36-month follow-up. METHODS: A randomized controlled clinical trial involving 130 women with SUI that had either SIMS or TOT. Primary outcomes: objective cure defined as negative cough stress and pad tests, and subjective cure reported as satisfaction and no desire for additional treatment. SECONDARY OUTCOMES: quality-of-life by IQOL and UDI-6 questionnaires, complications and reoperation rates. Student's t, χ2 , Fisher's exact, and Mann-Whitney tests, ANOVA and P < 0.05 as cut-off point were used for statistics. RESULTS: A total of 82 patients (n:41 each arm) completed 36-month follow-up. Objective cure was lower in the SIMS compared to TOT groups by both per protocol (68.3% and 90.2%, respectively, P = 0.027) and intention-to-treat analysis considering missing data as failures (40.6% and 60.7%, respectively, P = 0.035), while similar in both groups (81.2% and 93.4%, respectively) considering missing data as successes. Subjective cure rates were similar for both groups. TOT group presented better outcome regarding the avoidance and limiting behavior domain of IQOL (P = 0.021), and UDI-6 scores (P = 0.026). Seven out of 69 (10.1%) women in the SIMS group compared with two out of 61 (3.3%) in the TOT group (P = 0.172) had repeat surgery due to recurrent SUI at year follow up. CONCLUSION: TOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.

Two-years results of native tissue versus vaginal mesh repair in the treatment of anterior prolapse according to different success criteria: A randomized controlled trial.

AIMS: To compare efficacy and safety of the traditional colporraphy and transvaginal polypropylene mesh for the treatment of advanced anterior vaginal prolapse according to different success criteria in two-year follow-up. METHODS: In this randomized controlled trial, women with anterior prolapse stage II or greater, with Ba point ≥ +1 (POP-Q quantification), were randomly assigned to have either anterior colporraphy (n = 43) or transvaginal mesh repair (n = 43). The primary outcome was to compare objective success rate under two success definitions: prolapse stage I (Ba < -1) and stage II (Ba < 0). Secondary outcomes included complications and prolapse symptoms, satisfaction and quality of life (QoL). Intention to treat was used for the primary endpoint and per protocol analysis for the secondary outcomes. RESULTS: The groups presented similar preoperative data. Thirty three patients from the colporraphy and 37 from the mesh groups completed two-year follow-up. Under Ba < -1 definition, success rate was 39.53% for both groups (P = 1.00). Considering success as Ba < 0, analysis favored the mesh group by 23% (51.16% and 74.42%; 95% CI for difference: 3-43%; P = 0.022). Patients from the mesh group were more satisfied after two years (81.8% and 97.3% for colporraphy and mesh, respectively, 15.5% difference; 95% CI for difference 1-29%; P = 0.032). Both procedures similarly improved women's symptoms and QoL. Some complications were observed, one being a 13.5% mesh exposure rate. CONCLUSIONS: Transvaginal synthetic mesh repair for advanced anterior vaginal prolapse provided higher anatomical success and satisfaction rates compared with traditional colporraphy. Both procedures equally improved quality of life. Neurourol. Urodynam. 35:509-514, 2016. © 2015 Wiley Periodicals, Inc.

The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse. METHODS: This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance. RESULTS: The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05). CONCLUSIONS: Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

Monoprosthesis for anterior vaginal prolapse and stress urinary incontinence: midterm results of an international multicentre prospective study.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) can occur simultaneously with anterior vaginal prolapse (AVP) in up to 30% of patients. We studied a monoprosthesis that combines prepubic and transobturator arms for simultaneous treatment of AVP and SUI. METHODS: One hundred four women with AVP underwent surgical treatment using a monoprosthesis (NAZCA TC). POP-Q was used for anatomical evaluation. Functional results were evaluated by quality of life questionnaires, stress test and Stamey score. Patients were evaluated at 1, 3, 6 and 12 months postoperatively. RESULTS: There were significant and sustained improvements in points Aa, Ba and C. Positive stress test was observed in 29.8% preoperatively and decreased to 1.9% after 12 months. There was no significant impact in sexual symptoms. Mesh exposure was noted in 5.7% of patients. CONCLUSIONS: Monoprosthesis with combined prepubic and transobturator arms presented high success rates for AVP repair and simultaneous SUI treatment. It has also been shown to be safe and appears to preserve sexual function.

Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy.

INTRODUCTION AND HYPOTHESIS: This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse. METHODS: Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test. RESULTS: SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion. CONCLUSIONS: SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques.

Sexual function after anterior vaginal wall prolapse surgery.

OBJECTIVE: The aim of this study was to compare female sexual function after surgical treatment of anterior vaginal prolapse with either small intestine submucosa grafting or traditional colporrhaphy. METHODS: Subjects were randomly assigned, preoperatively, to the small intestine submucosa graft (n = 29) or traditional colporrhaphy (n = 27) treatment group. Postoperative outcomes were analyzed at 12 months. The Female Sexual Function Index questionnaire was used to assess sexual function. Data were compared with independent samples or a paired Student's t-test. RESULTS: In the small intestine submucosa group, the total mean Female Sexual Function Index score increased from 15.5±7.2 to 24.4±7.5 (p<0.001). In the traditional colporrhaphy group, the total mean Female Sexual Function Index score increased from 15.3±6.8 to 24.2±7.0 (p<0.001). Improvements were noted in the domains of desire, arousal, lubrication, orgasm, satisfaction, and pain. There were no differences between the two groups at the 12-month follow-up. CONCLUSIONS: Small intestine submucosa repair and traditional colporrhaphy both improved sexual function postoperatively. However, no differences were observed between the two techniques.

Sexual function after anterior vaginal wall prolapse surgery

OBJECTIVE: The aim of this study was to compare female sexual function after surgical treatment of anterior vaginal prolapse with either small intestine submucosa grafting or traditional colporrhaphy. METHODS: Subjects were randomly assigned, preoperatively, to the small intestine submucosa graft (n = 29) or traditional colporrhaphy (n = 27) treatment group. Postoperative outcomes were analyzed at 12 months. The Female Sexual Function Index questionnaire was used to assess sexual function. Data were compared with independent samples or a paired Student's t-test. RESULTS: In the small intestine submucosa group, the total mean Female Sexual Function Index score increased from 15.5±7.2 to 24.4±7.5 (p<0.001). In the traditional colporrhaphy group, the total mean Female Sexual Function Index score increased from 15.3±6.8 to 24.2±7.0 (p<0.001). Improvements were noted in the domains of desire, arousal, lubrication, orgasm, satisfaction, and pain. There were no differences between the two groups at the 12-month follow-up. CONCLUSIONS: Small intestine submucosa repair and traditional colporrhaphy both improved sexual function postoperatively. However, no differences were observed between the two techniques.