Summary of findings for the main comparison. Transobturator (TOR) compared to retropubic (RPR) route for stress urinary incontinence in women.
| Transobturator (TOR) compared to retropubic (RPR) route for stress urinary incontinence in women | ||||||
| Patient or population: women with stress urinary incontinence Settings: Secondary care Intervention: transobturator (TOR) Comparison: retropubic (RPR) route | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Retropubic (RPR) route | Transobturator (TOR) | |||||
| Subjective cure (Short term < 1 year) | Study population | RR 0.98 (0.96 to 1.00) | 5514 (36 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | ||
| 844 per 1000 | 827 per 1000 (810 to 844) | |||||
| Mean control group risk across studies | ||||||
| 833 per 1000 | 816 per 1000 (800 to 833) | |||||
| Subjective cure (medium term, 1 to 5 years) | Study population | RR 0.97 (0.92 to 1.03) | 683 (5 RCTs) | ⊕⊕⊝⊝ LOW 2,3 | ||
| 881 per 1000 | 854 per 1000 (810 to 907) | |||||
| Mean control group risk across studies | ||||||
| 869 per 1000 | 843 per 1000 (799 to 895) | |||||
| Subjective cure (long term, > 5 years) | Study population | RR 0.95 (0.87 to 1.04) | 714 (4 RCTs) | ⊕⊕⊕⊝ MODERATE 4 | ||
| 707 per 1000 | 671 per 1000 (615 to 735) | |||||
| Mean control group risk across studies | ||||||
| 843 per 1000 | 801 per 1000 (733 to 877) | |||||
| Bladder or urethral perforation | Study population | RR 0.13 (0.08 to 0.20) | 6372 (40 RCTs) | ⊕⊕⊕⊝ MODERATE 5 | ||
| 49 per 1000 | 6 per 1000 (4 to 10) | |||||
| Mean control group risk across studies | ||||||
| 25 per 1000 | 3 per 1000 (2 to 5) | |||||
| Voiding dysfunction (short and medium term, up to 5 years) | Study population | RR 0.53 (0.43 to 0.65) | 6217 (37 RCTs) | ⊕⊕⊕⊝ MODERATE 6 | ||
| 72 per 1000 | 38 per 1000 (31 to 47) | |||||
| Mean control group risk across studies | ||||||
| 55 per 1000 | 29 per 1000 (24 to 36) | |||||
| De novo urgency or urgency incontinence (short term, up to 12 months) | Study population | RR 0.98 (0.82 to 1.17) | 4923 (31 RCTs) | ⊕⊕⊕⊝ MODERATE 7 | ||
| 82 per 1000 | 80 per 1000 (67 to 96) | |||||
| Mean control group risk across studies | ||||||
| 83 per 1000 | 81 per 1000 (68 to 97) | |||||
| Groin pain | Study population | RR 4.62 (3.09 to 6.92) | 3226 (18 RCTs) | ⊕⊕⊕⊝ MODERATE 8 | ||
| 14 per 1000 | 66 per 1000 (44 to 99) | |||||
| Mean control group risk across studies | ||||||
| 45 per 1000 | 208 per 1000 (139 to 311) | |||||
| Suprapubic pain | Study population | RR 0.29 (0.11 to 0.78) | 1105 (4 RCTs) | ⊕⊕⊕⊝ MODERATE 9 | ||
| 29 per 1000 | 8 per 1000 (3 to 23) | |||||
| Mean control group risk across studies | ||||||
| 18 per 1000 | 5 per 1000 (2 to 14) | |||||
| Vaginal tape erosion (short and medium term, up to 5 years) | Study population | RR 1.13 (0.78 to 1.65) | 4743 (31 RCTs) | ⊕⊕⊕⊝ MODERATE 10 | ||
| 20 per 1000 | 22 per 1000 (15 to 32) | |||||
| Mean control group risk across studies | ||||||
| 21 per 1000 | 24 per 1000 (16 to 34) | |||||
| Repeat incontinence surgery (short term, within 12 months) | Study population | RR 1.64 (0.85 to 3.16) | 1402 (9 RCTs) | ⊕⊕⊕⊝ MODERATE 11 | ||
| 19 per 1000 | 31 per 1000 (16 to 60) | |||||
| mean control group across studies | ||||||
| 24 per 1000 | 39 per 1000 (20 to 76) | |||||
| Repeat incontinence surgery (long term, > 5 years) | Study population | RR 8.79 (3.36 to 23.00) | 695 (4 RCTs) | ⊕⊕⊝⊝ LOW 12,13 | ||
| 11 per 1000 | 100 per 1000 (38 to 262) | |||||
| Mean control group across studies | ||||||
| 67 per 1000 | 589 per 1000 (225 to 1000) | |||||
| Quality of life | 16 different validated questionnaires were used by different studies to assess QoL. This outcome was reported in 11 RCTs, but reported in different ways which precluded meta‐analysis. In all but one of the RCTs where QoL was assessed there was improvement in the QoL in women after the intervention, irrespective of which route was used, with no significant difference in scores between groups. Where assessment of sexual function was performed, there was an equal amount of improvement in sexual function following surgical treatment, irrespective of the route employed | ‐ | (11 RCTs) | |||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CAD: Canadian dollars CI: confidence interval RCT: randomised controlled trial RPR: retropubic route RR: risk ratio QoL: quality of life TOR: transobturator route | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Very low quality: We are very uncertain about the estimate | ||||||
1Random sequence generation was unclear in 13 studies and at high risk of bias in 2 studies, and allocation concealment was unclear in 20 studies and at high risk in 2/37 studies
2Allocation concealment was unclear in 2/5 trials and sequence generation was unclear in 1/5 trials, so we decided to downgrade by 1 level
3There was potential substantial heterogeneity with an I² value of 67%, so we downgraded the quality rating by 1 level
4There was potential substantial heterogeneity among studies with an I² value of 65%, which lead us to downgrade by 1 level
5As allocation concealment was unclear in 18/40 trials and at high risk in 3/40, and sequence generation was unclear in 14/40 trials and at high risk in 3/40, we decided to downgrade by 1 level
6As allocation concealment was unclear in 16/37 trials and at high risk in 2/37, and sequence generation was unclear in 11/37 trials and at high risk in 2/37, we decided to downgrade by 1 level
7Random sequence generation was unclear in 10/31 studies and at high risk of bias in 2/31, and allocation concealment was unclear in 15/31 studies and at high risk in 2/31, so we downgraded by 1 level
8Random sequence generation was unclear in 4/18 studies and at high risk in 2/18, and allocation concealment was unclear in 9/18 studies and at high risk in 2/18, so we downgraded the quality of the evidence by 1 level
9Random sequence generation was at high risk in 1/4 studies, while allocation concealment was unclear in 2/4 and at high risk in 1/4, so we downgraded by 1 level
10Allocation concealment was unclear in 12/31 trials and at high risk in 1/31, while sequence generation was unclear in 6/31 trials and at high risk in 1/31, so we decided to downgrade by 1 level
11The wide confidence interval was judged to include a threshold for appreciable harm considered to be > 25% increase in RR, in this case there was much more than a 25% increase in RR for harm, so we downgraded the level by 1
12There was potential substantial heterogeneity with an I² value of 46%, so we downgraded the quality rating by 1 level
13Due to the low number of studies reporting data for this outcome, and the low number of events and wide CI around the estimate of the effect, we downgraded the quality of evidence by 1 level due to imprecision