Summary of findings 3. Obturator medial‐to‐lateral approach compared to obturator lateral‐to‐medial approach for stress urinary incontinence in women.
| Obturator medial‐to‐lateral approach compared to obturator lateral‐to‐medial approach for stress urinary incontinence in women | ||||||
| Patient or population: women with stress urinary incontinence Settings: Secondary care Intervention: obturator medial‐to‐lateral approach Comparison: obturator lateral‐to‐medial approach | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Obturator lateral‐to‐medial approach | Obturator medial‐to‐lateral approach | |||||
| Subjective cure (short term ≤ 1 year) | Study population | RR 1.00 (0.96 to 1.06) | 759 (6 RCTs) | ⊕⊕⊝⊝ LOW 1 | ||
| 877 per 1000 | 877 per 1000 (842 to 930) | |||||
| Mean control group risk across studies | ||||||
| 880 per 1000 | 880 per 1000 (845 to 933) | |||||
| Subjective cure (medium term, 1 to 5 years) | Study population | RR 1.06 (0.91 to 1.23) | 235 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 | ||
| 711 per 1000 | 753 per 1000 (647 to 874) | |||||
| Mean control group risk across studies | ||||||
| 736 per 1000 | 780 per 1000 (670 to 905) | |||||
| Subjective cure | No studies reported this outcome | ‐ | (0 studies) | |||
| Bladder or urethral perforation | Study population | RR 0.38 (0.07 to 1.92) | 794 (6 RCTs) | ⊕⊕⊕⊝ MODERATE 3 | ||
| 11 per 1000 | 4 per 1000 (1 to 20) | |||||
| Mean control group risk across studies | ||||||
| 6 per 1000 | 2 per 1000 (0 to 12) | |||||
| Voiding dysfunction (short and medium term, up to 5 years) | Study population | RR 1.74 (1.06 to 2.88) | 1121 (8 RCTs) | ⊕⊕⊕⊝ MODERATE 4 | ||
| 40 per 1000 | 70 per 1000 (43 to 116) | |||||
| Mean control group risk across studies | ||||||
| 55 per 1000 | 96 per 1000 (58 to 158) | |||||
| De novo urgency or urgency incontinence (short term, up to 12 months) | Study population | RR 1.01 (0.46 to 2.20) | 357 (3 RCTs) | ⊕⊕⊝⊝ LOW 5 | ||
| 63 per 1000 | 63 per 1000 (29 to 138) | |||||
| Mean control group risk across studies | ||||||
| 64 per 1000 | 65 per 1000 (29 to 141) | |||||
| Groin pain | Study population | RR 1.15 (0.75 to 1.76) | 837 (6 RCTs) | ⊕⊝⊝⊝ VERY LOW 6,7 | ||
| 80 per 1000 | 92 per 1000 (60 to 140) | |||||
| Mean control group risk across studies | ||||||
| 74 per 1000 | 85 per 1000 (56 to 130) | |||||
| Vaginal tape erosion (short and medium term, up to 5 years) | Study population | RR 0.42 (0.16 to 1.09) | 1087 (7 RCTs) | ⊕⊝⊝⊝ VERY LOW 7,8 | ||
| 24 per 1000 | 10 per 1000 (4 to 26) | |||||
| Mean control group risk across studies | ||||||
| 17 per 1000 | 7 per 1000 (3 to 19) | |||||
| Repeat incontinence surgery (short term, up to 12 months) | Study population | RR 0.64 (0.32 to 1.30) | 532 (2 RCTs) | ⊕⊕⊝⊝ LOW 7,9 | ||
| 71 per 1000 | 45 per 1000 (23 to 92) | |||||
| Mean control group risk across studies | ||||||
| 58 per 1000 | 37 per 1000 (19 to 75) | |||||
| Repeat incontinence surgery | No studies reported this outcome | ‐ | (0 studies) | |||
| Quality of life | The mean quality of life in the control group was 0 | The mean quality of life in the intervention group was 16.54 higher (4.84 higher to 28.24 higher) | ‐ | 46 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 10,11 | |
| *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).
CI: confidence interval RCT: randomised controlled trial RR: risk ratio; | ||||||
| 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 4/6 studies, allocation concealment was unclear in5/6 and at high risk in 1/6 studies, so we downgraded the quality of evidence due to risk of bias by 2 levels
2Random sequence generation was unclear in all both studies, allocation concealment was unclear in 1 and high risk of bias in the other study, so we downgraded by 2 levels
3Sequence generation was unclear in 2 studies and allocation concealment was unclear in 3 studies, so we downgraded the quality rating by 1 level
4Sequence generation was unclear in 3 studies and at high risk in 1 study, while allocation concealment was unclear in 4 studies and at high risk in 1 study, so we downgraded by 1 level
5Sequence generation was unclear in 2/3 studies and at high risk in 1/3, allocation concealment was unclear in 2/3 studies and high in 1/3, so we downgraded by 2 levels
6Random sequence generation was unclear in 2/5 and high in 1/5 studies, while allocation concealment was unclear in 2/5 and high in 2/5 studies, so we downgraded the quality of evidence due to high risk of bias by 2 levels
7The wide confidence interval was judged to include a threshold for appreciable harm considered to be > 25% increase in RR, in this case there was > 65% increase in RR for harm, so we downgraded by 1 level
8Sequence generation was unclear in 3/7 studies and at high risk in 1/7. Allocation concealment was unclear in 5/7 studies and at high risk in 1/7. We downgraded the quality rating by 2 levels
9Sequence generation and allocation concealment were unclear in 1/2 studies, so we downgraded by 1 level
10Sequence generation and allocation concealment were unclear, so we downgraded by 1 level
11As there was only 1 study with very few events and CIs around estimates of effect included appreciable benefit and appreciable harm, we downgraded by 2 levels