Suburethral Sling for Stress Urinary Incontinence

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A; SPIRA, C

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Urinary Incontinence (UI) is a very common pathology affecting 4% to 40% of women, specially over 50 years old. The International Continence Society defines it as the "involuntary and objectively demonstrable loss of urine through the urethra.?. Deliveries, gynecological surgeries, hormone changes, constipation and overweight are the main related or triggering causes. Traditionally, Burch surgery (open abdominal retropubic colposuspension) has been considered the "gold standard treatment", with a 69% to 90% effectiveness. However, its severe complications, morbidity and relapses made new less invasive techniques such as the suburethral sling a matter of research. Technology Sling is a minimally invasive surgical technique that consists of placing a sling (both artificial or made of autologous tissue) under the middle urethra. Though there are many variations, the most commonly used is TVT (Tension-free Vaginal Tape). In order to reduce complications such as extended deep hematoma, lesions to the great vessels or intestine, a new technique called TOT (Transobturador Tape) and more recently the MISS (Minimally invasive synthetic sling) has been developed. Purpose To assess the available evidence on the efficacy, safety and coverage policy related aspects for the use of sling in patients with stress urinary incontinence (SUI). Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results Two Cochrane systematic reviews, 18 RCTs, one economic evaluation, one clinical practice guideline, one health technology assessment and five coverage policies were selected. Those most commonly used techniques and relevant results are described below. Suburethral Slings One systematic review published in 2012 included 26 studies (n=2,284) assessing the effects of suburethral slings in comparison with other therapeutic alternatives /drugs, open abdominal retropubic colposuspension - Burch surgery -, injection agents, suspension needles, minimally invasive slings - SSSMI- and suburethral slings made of different materials) for SUI. No significant differences were observed between suburethral slings and MISS in terms of clinically reported incontinence (defined as lack of incontinence) after one year, or between sling and the Burch surgery. However, higher rates of perioperative complications were evidenced with suburethral slings vs. MISS (RR= 1.59, 95%CI 1.03 to 2.44). Tension-free Vaginal Tape (TVT) versus Transobturator Sling (TOT or TVT-O) Six prospective studies agree on the fact that both procedures are equally effective in terms of short-term clinically reported incontinence, evidencing more episodes of inguinal pain in the TOT group, while the TVT group showed more bleeding episodes. Minimally Invasive Suburethral Sling (MISS). One 2009 systematic review included 62 studies (n=7,101) where the effects of MISS were compared with other therapeutic alternatives (conventional suburethral slings, open abdominal retropubic colposuspension, laparoscopic colposuspension and with other MISS). No differences in clinically reported incontinences after one year in comparison with conventional slings or in Burch surgery were observed, but the surgical time for both procedures was longer than with MISS (DM 15.5 min; 95%CI 12.7 to 18.2 for Burch Surgery). By evaluating MISS, the bottom to top technique was more effective in terms of short-term clinically reported incontinence than the top to bottom technique (RR=1.10; 95%CI 1.01 to 1.20). Clinical Practice Guidelines The Canadian Society of Gynecologist and Obstetricians consider that TVT slings are an efficacy alternative equivalent to the Burch surgery for the treatment of SUI and that TOT is an alternative to TVT. The Health and Clinical Excellence Institute, in addition, suggests that retropubic or transobturator tapes should be used in case of failure of conventional treatments. No guidelines making reference to MISS have been found. Coverage Policies Several United States health sponsors approve the use of suburethral slings in case medical treatments have failed or are contraindicated. Costs The cost of slings (suburethral tapes), according to local financial sources, ranges from AR$2,700 ? AR$4,500 (Argentine pesos 2012) depending on the supplier and the cost of the implant module is approximately AR$4,300 (Argentine pesos 2012). Conclusions There is evidence of good methodological quality showing that sling techniques, at short term, would be as effective as Burch surgery, in terms of clinically reported incontinence, for the treatment of stress urinary incontinence. There is no medium or long-term evidence. No significant differences were found among the existing sling techniques in terms of efficacy but they have difference degrees of safety profiles. Both the clinical practice guidelines and the coverage policies endorse the use of suburethral slings when conventional treatments have failed.