A Cochrane review «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 compared the effectiveness and safety of retropubic (TVT) versus transobturator (TOT/TVT-O) mid-urethral slings. In short term follow-up (under 1 year), subjective cure rates were similar. In TOT/TVT-O group 83% and in TVT group 84% of patients reported having no urinary incontinence symptoms. The impact was similar but less certain in moderate (1-5 years) and long term (over 5 years) follow ups.
TOT/TVT-O leads more often to reoperation (risk difference 10.2 %, over 5 years follow up) and groin pain (risk difference 4.8 %). Other complications were higher for TVT: major hematoma or visceral injury (risk difference 1.7 %), voiding dysfunction (risk difference 3.3 %), suprapubic pain (risk difference 1.2 %), and bladder or urethral perforation (risk difference 4.8 %).
The evidence certainty was downgraded due to risk of bias and imprecision.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis | |||||
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | SR/MA | Women with stress or mixed urinary incontinence | Retropubic vs transobturator sling | Subjective cure, complications | Moderate |
| Reference | Comments |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Risk of bias moderate, mainly due to unclear blinding procedures for patients and outcome assessors. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) RPR | Absolute number of events (%) TOR | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence in is downgraded due to study limitations (mostly due to unclear reporting of random sequence generation and allocation concealment) I=intervention; C=comparison; CI=confidence interval; PGI-1 |
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| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | 36 trials, 2640/2693 |
One year | 2219 (84 %) | 2202 (81.8 %) | 0.98 (0.96-1.00) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) RPR | Absolute number of events (%) TOR | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence in is downgraded one level due to imprecision and inconsistency. I=intervention; C=comparison; CI=confidence interval; PGI-1 |
|||||
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | 5 trials (344/339) |
1-5 years | 303 (88.1 %) | 291 (84.6 %) | 0.97 (0.87-1.09) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) RPR | Absolute number of events (%) TOR | Relative effect (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: low The quality of evidence in the long term is downgraded two levels due to inconsistency and imprecision. I=intervention; C=comparison; CI=confidence interval; PGI-1 |
|||||
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | 4 trials (341/373) | Over 5 years | 241 (70.1 %) | 243 (65.1 %) | 0.95 (0.80-1.12) |
| Reference | Complication | TVT Number of events % |
TOT/TVT-O Number of events % |
Risk Ratio (95% CI) |
|---|---|---|---|---|
| Level of evidence: Major hematoma or visceral injury: moderate (study limitations) Voiding dysfunction: moderate (study limitations) De novo urge: moderate (imprecision and study limitations) Vaginal tape erosion: moderate (imprecision and study limitations) Groin pain: moderate (imprecision and study limitations) Suprapubic pain: Moderate (imprecision and study limitations) Bladder/urethral perforation: Moderate (study limitations) Repeat surgery, 1 year: Moderate (imprecision, study limitations) Repeat surgery, 1 to 5 years: Moderate (imprecision, study limitations) Repeat surgery, over 5 years: Moderate (imprecision, study limitations) |
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| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Major hematoma or visceral injury | 48/2317 2,1 % |
10/2359 0,4 % |
0.33 (0.19-0.55) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Voiding dysfunction | 222/ 3072 7,2% |
122/3128 3,9% |
0.53 (0.43-0.65) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | De novo urge incontinence | 202/2463 8,2 % |
209/2460 8,5 % |
0.98 (0.82-1.17) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Vaginal tape erosion | 47/2298 2,0% |
47/2270 2,1% |
1.13 (0.78-1.65) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Groin pain | 16/1512 1,1% |
90/1538 5,9% |
4.62 (3.09-6.92) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Suprapubic pain | 16/548 2,9% |
4/557 0,72% |
0.29 (0.11-0.78) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Bladder perforation | 154/3069 5,0% |
5/3104 0.2% |
0.12 (0.08-0.20) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Repeat surgery, 1 year |
8/586 1,4% |
14/635 2,2% |
1.69 (0.75-3.80) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Repeat incontinence surgery 1 to 5 years follow up |
1/180 0,6% |
32/175 18,3% |
21.89 (4.36-109.77) |
| «Ford AA, Rogerson L, Cody JD, et al. Mid-urethral ...»1 | Repeat surgery, over 5 years |
4/351 1,1% |
39/344 11,3% |
8.79 (3.36-23.00) |