Summary of findings for the main comparison. Transurethral radiofrequency collagen denaturation compared with no treatment/sham treatment for women with UI.
| Transurethral radiofrequency collagen denaturation compared with no treatment/sham treatment for women with UI | ||||||
| Patient or population: women with symptomatic UI Settings: academic and community practices in the United States Intervention: transurethral radiofrequency collagen denaturation Comparison: no treatment/sham treatment | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| No treatment/sham treatment | Transurethral radiofrequency collagen denaturation | |||||
| Participant‐reported measures: number of women reporting UI symptoms | ‐ | ‐ | Not estimable | 0 (0 studies) | ‐ | No evidence available |
| Serious adverse events Follow‐up: 12 months |
0 per 1000 | 0 per 1000 (0 to 0) | Not estimable | 173 (1 RCT) | ⊕⊕⊝⊝ Lowa,b | No serious adverse events occurred in 1 included study |
| Disease‐specific quality of life: number of women with an I‐QOL score improvement ≥ 10 points at 12 months | 434 per 1000 | 482 per 1000 (334 to 703) | RR 1.11 (0.77 to 1.62) | 142 (1 RCT) | ⊕⊕⊝⊝ Lowa,c | |
| Repeat continence surgery: number of women undergoing repeat continence surgery | ‐ | ‐ | Not estimable | 0 (0 studies) | ‐ | No evidence available |
| Other adverse event: pain/dysuria: dysuria Follow‐up: 12 months |
16 per 1000 | 91 per 1000 (12 to 694) | RR 5.73 (0.75 to 43.70) | 173 (1 RCT) | ⊕⊕⊝⊝ Lowa,d | |
| Other adverse event: (new) detrusor overactivity: overactive bladder symptoms Follow‐up: 12 months |
127 per 1000 | 173 per 1000 (80 to 372) | RR 1.36 (0.63 to 2.93) | 173 (1 RCT) | ⊕⊕⊝⊝ Lowa,d | |
| Other adverse event: urinary tract infection Follow‐up: 12 months |
48 per 1000 | 45 per 1000 (11 to 184) | RR 0.95 (0.24 to 3.86) | 173 (1 RCT) | ⊕⊕⊝⊝ Lowa,d | |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference; I‐QOL: Incontinence Quality of Life; RCT: Randomised controlled trial; RR: Risk ratio; UI: Urinary incontinence. | ||||||
| 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. | ||||||
aDowngraded for study limitations (‐1): high risk of bias.
bDowngraded for imprecision (‐1): no events in small study.
cDowngraded for imprecision (‐1): confidence interval includes both no effect and appreciable benefit; low numbers of events.
dDowngraded for imprecision (‐1): confidence interval includes no effect and both appreciable benefit and appreciable harm; low numbers of events.