Guidance
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 systematic review and meta-analysis of 3,308 women from 26 randomised controlled trials (RCTs) comparing single-incision mini sling (SIMS, n=1,735) procedures with standard midurethral sling (SMUS, n=1,573) procedures in women with stress urinary incontinence, there was no statistically significant difference in objective cure rates at a mean follow-up of 18.6 months between SIMS (tension-free vaginal tape [TVT] 'Secur' trials excluded) and SMUS (risk ratio [RR] 0.98; 95% confidence interval [CI] 0.94 to 1.01, n=11, I2=7%). There were similar results when SIMS was compared with transobturator tension-free vaginal tape (TOT, RR 0.98; 95% CI 0.94 to 1.01, n=10, I2=11%) and with retropubic tension-free vaginal tape (r‑TVT, RR 0.81; 95% CI 0.48 to 1.40, n=1).
4.2 In the systematic review and meta-analysis of 3,308 women, there was no statistically significant difference in patient-reported cure rates at a mean follow-up of 18.6 months between SIMS ('TVT Secur' trials excluded) and SMUS (RR 0.94; 95% CI 0.88 to 1.00, n=11, I2=57%). There were similar results when SIMS was compared with TOT (RR 0.96; 95% CI 0.92 to 1.00, n=9, I2=20%) and with r‑TVT (RR 0.71; 95% CI 0.42 to 1.20, n=2, I2=75%).
4.3 In a Cochrane systematic review and meta-analysis of 3,290 women with stress urinary incontinence from 31 randomised or quasi-randomised trials, women were more likely to remain incontinent after surgery with SIMS (41% [121/292]) than with r‑TVT (26% [72/281]; RR 2.08, 95% CI 1.04 to 4.14). Four out of 5 studies in the comparison included 'TVT Secur', which has been withdrawn from use as a single-incision sling. In the same study, incontinence rates were also higher with SIMS than with inside-out TOT (30% versus 11%; RR 2.55, 95% CI 1.93 to 3.36). However, if the trials in which 'TVT Secur' was not used were excluded, it showed that a high risk of incontinence was mainly associated with use of this device (RR 2.65, 95% CI 1.98 to 3.54). The evidence was insufficient to show a difference in incontinence rates with other SIMS ('TVT Secur' trials excluded) compared with inside-out or outside-in TOT.
4.4 In an RCT of 80 women (40 SIMS versus 40 TOT), there were no statistically significant differences between groups for the cough stress pad test (CSPT) values before and after the procedure. However, there were statistically significant differences within groups in CSPT values before and after the procedure (mean±standard deviation, grams: 71±18 versus 0.66±0.8 in the SIMS group, p=0.0001, and 73±27 versus 0.41±0.4 in the TOT group, p=0.0002).
4.5 In a prospective case series of 120 women treated by SIMS, the mean daily pad use decreased statistically significantly from 2.4 before the procedure to 0.1 at 1 month and 0.2 at 12 months (p<0.01 versus baseline).
4.6 In a prospective comparative study of 240 women treated by SIMS (n=120) or r‑TVT (n=120), detrusor instability scores did not change statistically significantly in the SIMS group from baseline (2.1±1.3 versus 2.2±1.3 at 24 months after the procedure). In the r‑TVT group, the scores statistically significantly worsened from baseline (2.4±1.5 versus 2.9±1.9 at 24 months, p<0.05).
4.7 In the prospective case series of 120 women, the mean urogenital distress inventory scores (a 6‑item questionnaire) decreased statistically significantly from 65% before the procedure to 3% at 1 month and 13% at 12 months (p<0.01 versus baseline).
4.8 In the prospective case series of 120 women, the mean Incontinence impact scores (a 7‑item short-form questionnaire) decreased statistically significantly from 87% before the procedure to 3% at 1 month and 13% at 12 months (p<0.01 versus baseline).
4.9 In an RCT of 225 women treated by SIMS (n=112) or TOT (n=113), the proportion of women using antimuscarinics 12 months after the procedure was statistically significantly lower in the SIMS group than in the TOT group (6% [5/87] versus 16% [15/95], p=0.034).
4.10 In the systematic review and meta-analysis of 3,308 women, women with SIMS ('TVT Secur' trials excluded) returned to normal activities statistically significantly earlier (weighted means difference [WMD] 5.08 days; 95% CI −9.59 to −0.56, n=2, I2=63%) and to work statistically significantly earlier (WMD −7.20 days; 95% CI −12.43 to −1.98, n=2, I2=38%).
4.11 In the systematic review and meta-analysis of 3,308 women, there was no statistically significant difference in quality-of-life scores (measured with the Incontinence Impact Questionnaire–Short Form IIQ7 and King's Health Questionnaire 7) between SIMS ('TVT Secur' trials excluded) and SMUS (WMD 1.23; 95% CI −2.76 to 5.21, n=3, I2=56%). All 3 RCTs included in the analysis reported improvement in quality-of-life scores at follow-up compared with baseline, with no statistically significant differences between SIMS and SMUS.
4.12 In the prospective comparative study of 240 women treated by SIMS (n=120) or r‑TVT (n=120), patient satisfaction (assessed using a visual analogue scale [0 to 10, from low to high satisfaction]) was 7.5±2.6 in the SIMS group compared with 7.4±1.7 in the r‑TVT group (level of significance not stated).
4.13 In the systematic review and meta-analysis of 3,308 women, there was no statistically significant difference in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ12) scores between SIMS ('TVT Secur' trials excluded) and SMUS at a mean 18‑month follow-up (WMD 0.39; 95% CI −0.89 to 1.67, n=2, I2=17%).
4.14 The specialist advisers listed the following key efficacy outcomes: objective and subjective cure of stress urinary incontinence, reduction in stress urinary leakage and reduction in stress incontinence episodes for more than 1 year.
4.15 Twenty two commentaries from patients who had experience of this procedure were received, which were discussed by the committee.