4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a randomised controlled trial (RCT) of 865 women with anterior or posterior vaginal wall prolapse treated by synthetic mesh augmented repair or standard repair alone, there were no statistically significant differences in prolapse symptom scores (5.3 versus 4.9 respectively, p=0.37). There were also no statistically significant differences in symptomatic prolapse (85% [291/341] compared with 82% [283/347] respectively, p=0.30) or the proportion of women reporting 'something coming down' (34% [116/342] compared with 31% [106/347] respectively, p=0.59) at 2‑year follow‑up. The quality-of-life scores were also similar. In an RCT of 735 women with anterior or posterior vaginal wall prolapse treated by biological graft augmented repair or standard repair alone, there were no statistically significant differences in prolapse symptom scores (5.5 compared with 4.9 respectively, p=0.43) or symptomatic prolapse (82% [245/299] compared with 81% [242/298] respectively, p=0.85). The proportion of women reporting 'something coming down' was statistically significantly higher in the graft augmented repair group (40% [120/299] compared with 31% [91/298] in the standard repair alone group, p=0.04) at 2‑year follow‑up. The quality-of-life scores were similar between the 2 groups.

4.2 In a systematic review of 4,023 patients, there was a statistically significantly lower risk of awareness of prolapse in women treated by transvaginal permanent mesh repair compared with native tissue repair (relative risk [RR] 0.66, 95% confidence interval [CI] 0.54 to 0.81; n=1,614, 12 RCTs) at 1- to 3‑year follow‑up.

4.3 In the RCT of 865 women with anterior or posterior vaginal wall prolapse treated by synthetic mesh augmented repair or standard repair alone, there were no statistically significant differences in the proportions of women with an overall Pelvic Organ Prolapse Quantification (POP‑Q) score of 2b, 3 or 4 (16% [54/336] compared with 14% [47/338] respectively, p=0.52) at 1‑year follow‑up. In the RCT of 735 women with anterior or posterior vaginal wall prolapse treated by biological graft augmented repair or standard repair alone, the proportions of women with an overall POP‑Q score of 2b, 3 or 4 were 18% (54/298) and 16% (47/303) respectively at 1‑year follow‑up (p=0.47). In the systematic review of 4,023 patients, women who had a transvaginal mesh repair were less likely to have a stage 2 or worse anterior compartment prolapse on examination than those having a native tissue repair (RR 0.45, 95% CI 0.36 to 0.55, 13 RCTs, n=1,406, I2=35%) at 1- to 3‑year follow‑up. The risk of recurrent prolapse was lower in the transvaginal permanent mesh group than in the native tissue repair group (RR 0.40, 95% CI 0.30 to 0.53, 21 studies, n=2,494, I2=73%).

4.4 In the systematic review of 4,023 patients, those who had a transvaginal mesh repair were less likely to have repeat surgery for prolapse (RR 0.53, 95% CI 0.31 to 0.88, 12 RCTs, n=1,675) at 1‑ to 3‑year follow‑up than those who had native tissue repair. In a population-based cohort study of 27,809 patients who had mesh or native tissue repair, surgery for recurrent prolapse was reported in similar proportions of patients: 5% of patients in both groups at 1‑year follow‑up, and 10% (95% CI 9 to 12%) in the mesh group at 5‑year follow‑up compared with 9% (95% CI 9 to 10%) in the native tissue group. In the RCT of 865 patients who had synthetic mesh or standard repair, further prolapse surgery was needed in a similar proportion of patients (4% [15/343] compared with 5% [16/348] respectively) at 2‑year follow‑up. In the RCT of 735 patients who had biological graft or standard repair, further prolapse surgery was needed in 5% of patients in both groups (15/300 and 15/299) at 2‑year follow‑up.

4.5 The specialist advisers listed anatomical success, restoration of bladder, bowel and sexual function, and long-term success as the key efficacy outcomes.

4.6 Sixteen commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)