A randomized control study comparing retropubic mid-urethral sling (TVT) vs. transobturator tape (Monarc) in the treatment of women with USI and ISD. Long term follow up with mean of 12 years.

Abstract

Objective: Comparison of the efficacy of retropubic (RP)to transobturator tape (TOT) mid-urethral sling (MUS) in the treatment of women with stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD) with a minimum follow up of 12 years. Method(s): 164 women were randomized to either receive RP or TOT MUS as treatment of urodynamic stress incontinence and intrinsic sphincter deficiency. Concomitant pelvic organ prolapse surgery was admissible. The primary outcome assessed after >=12 years follow-up was symptomatic SUI requiring repeat surgery. Secondary outcomes were assessed by phone interview and validated questionnaires evaluating quality of life. The question, if the procedure would be recommended to a family friend or relative was asked. Result(s): 164 women were enrolled and randomized to one of the MUS. 12 years after enrollment, 1 of the 82 (1.2 %) in the RP group had undergone repeat surgery to correct SUI compared to 20 of the 82 (24.4%) women in the TOT group. The repeat surgeries consisted of 20 RPMUS placements and 1 pubovaginal sling (in TOT group). If RPMUS had been used exclusively, repeat surgery for SUI would have been avoided in one in 5 (95%CI 4 to 8) patients. The risk ratio of repeat surgery was 19 (95%CI 3 to 139 p < 0.001) times greater in the TOT group. In the TOT group, the median time to repeat surgery was 32 months compared with 43 months for RP group (P<0.46). Results such as recurrent SUI, overactive bladder symptoms and complications are reported in Table 1. The quality-of-life outcomes UDI 6 (total & subscores questions 2,3 &5) and IIQ7 were not different either between groups or across duration of follow-up in women not requiring repeat sling. The positive reply to recommending the surgery to a friend was similar in both groups. The rate of surgery for complications was 2-3%. Conclusion(s): The cure rate for urodynamic SUI with ISD is significantly higher for the RP compared with the TOTMUS. Urodynamic assessment of urethral closure pressure and Valsalva leak point pressures appears to be of value in the identification of the women in the subgroup with USI and ISD who would benefit from the retropubic route at the time ofMUS insertion.