The quality of evidence (I-III) and classification of recommendations (A-E) are defined at the end of the "Major Recommendations."
- Tension-free vaginal tape (TVT) can be offered as an alternative of equal efficacy to the Burch procedure for the surgical management of stress urinary incontinence. (I-A)
- Transobturator tape (TOT) can be offered as an alternative to tension-free vaginal tape that eliminates the risks of intra-abdominal organ injury. It should be offered with the proviso that its long-term effectiveness and safety relative to tension-free vaginal tape remain to be determined. (II-B)
- Midurethral sling procedures performed through a single suburethral incision should be used only in the setting of a clinical trial until their effectiveness and safety are proven. (III-C)
- Despite the suggested simplicity of pre-packaged surgical kits for midurethral procedures, specific training is recommended prior to performing any of these surgical procedures. (III-C)
Discussion
Since their introduction, minimally invasive midurethral procedures used to treat stress incontinence have been aggressively marketed to surgeons and, in many cases, have supplanted the gold standard Burch procedure. While the evidence now supports the substitution of the TVT procedure for the Burch, it provides very little support for other midurethral procedures. TOT was introduced as a purportedly safer procedure of equal effectiveness to TVT. In considering the rationale for the introduction of TOT it must be remembered that serious retropubic complications from the TVT are rare. While the use of TOT has eliminated the serious retropubic risks, it has introduced a new set of complications. Rates for more minor complications appear to be similar for the two procedures. Therefore, the effectiveness of the procedure should guide selection and patient counselling. TVT has undergone the most rigorous testing; it must therefore be considered superior to the other midurethral procedures until further scientific evidence demonstrates equivalency for another procedure. TOT has demonstrated good short-term results. Other midurethral procedures are currently unsupported by any reliable evidence.
Definitions:
Quality of Evidence Assessment*
I: Evidence obtained from at least one properly designed randomized controlled trial.
II-1: Evidence from well-designed controlled trials without randomization.
II-2: Evidence from well-designed cohort (prospective or retrospective) or case–control studies, preferably from more than one center or research group.
II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results from uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category.
III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Classification of Recommendations**
- There is good evidence to recommend the clinical preventive action.
- There is fair evidence to recommend the clinical preventive action.
- The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making.
- There is fair evidence to recommend against the clinical preventive action.
- There is good evidence to recommend against the clinical preventive action.
*The quality of evidence reported in these guidelines has been adapted from the Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care
**Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care.
