Summary of findings 3.
Biological repair versus native tissue repair for vaginal prolapse
| Biological repair versus native tissue repair for vaginal prolapse | ||||||
|
Population: women with vaginal prolapse Settings: surgical Intervention: biological repair Control: native tissue repair | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Native tissue repair | Biological repair | |||||
|
Awareness of prolapse at 1 to 3 years |
105 per 1000 | 102 per 1000 (68 to 151) | RR 0.97 (0.65 to 1.43) | 777 (7 studies) | ⊕⊕⊝⊝ low1,2 | |
|
Repeat prolapse surgery 1 to 2 years |
43 per 1000 | 52 per 1000 (26 to 105) | RR 1.22 (0.61 to 2.44) | 306 (5 studies) | ⊕⊕⊝⊝ low3,4 | |
|
Recurrent prolapse at 1 year |
295 per 1000 | 277 per 1000 (177 to 434) | RR 0.94 (0.60 to 1.47) | 587 (7 studies) | ⊕⊝⊝⊝ very low3,5,6 | |
| Bladder injury | Not estimable as only 1 event occurred (in the native tissue group) | 137 (1 study) |
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| Bowel injury | Not estimable as only 1 event occurred (in the biological repair group) | 137 (1 study) |
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|
De novo dyspareunia (pain during sexual intercourse) review 1 to 3 years |
177 per 1000 | 150 per 1000 (35 to 648) | RR 0.85 (0.20 to 3.67) | 37 (1 study) | ⊕⊝⊝⊝ very low3,8 | |
|
De novo urinary stress incontinence at 1 year |
Not estimable ‐ no events occurred | 56 (1 study) | ||||
|
Quality of life at 1 year |
The mean quality of life in the biological repair group was 0.05 standard deviations lower (0.48 lower to 0.38 higher). This is an imprecise finding that is consistent with a small benefit in either group, or else no difference between the groups | 84 (2 studies) | ⊕⊝⊝⊝ very low9 | |||
| *The basis for the assumed risk is the median control group risk across studies. 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; 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. | ||||||
1Downgraded one level due to serious risk of bias: four of the studies at high or unclear risk of bias associated with blinding status. 2Downgraded one level due to serious imprecision: confidence intervals compatible with benefit in either group or with no difference between the groups. 3Downgraded one level due to imprecision: confidence interval compatible with benefit in either group or with no difference between groups. 4Downgraded one level due to serious risk of bias in 3/5 studies: two studies at high risk of attrition bias, and one study not blinded. 5Downgraded one level due to serious risk of bias: three studies rated at high risk of attrition bias, detection bias, and other bias (conflict of interest), respectively. 6Downgraded one level due to serious inconsistency: I2 = 59% indicating substantial statistical heterogeneity.
7Downgraded one level due to serious risk of bias: blinding status unclear.
8Downgraded two levels due to very serious imprecision: single small study, only six events.
9Downgraded one level due to serious risk of attrition bias, and a further two levels due to very serious imprecision: only 84 participants.