Prospective randomized trial comparing TVT-O™ versus its modification TVT Abbrevo™

A. Thomas, D. Waltregny, J. de Leval

Aims. To compare a modified insideout transobturator procedure, using a shortened sling and reduced dissection, with its original counterpart (TVT-O™) for the treatment of female stress urinary incontinence (SUI).

Materials and methods. Randomized, single-blinded, prospective trial in which women suffering from SUI were randomized to the original or modified procedure as sole surgery. Modifications to the original procedure were twofold: 1. the tape was shortened to 12 cm without any changes to mesh’s characteristics and 2. during lateral dissection, perforation of the obturator membrane by the scissors and guide was avoided. A standardized postoperative analgesia protocol was followed, including ondemand administration of analgesics. The results of the treatment were estimated in 1 year.

Results. Between 01/2007 and 12/2008, 87 and 88 were recruited in the modified and original TVTO ™ procedure groups, respectively. Baseline patients characteristics were similar in the 2 groups (p>0.05). No intraoperative complication was recorded. Among the 170 (97%) patients who completed the 1 year follow- up, the SUI cure rate was 91.2% and no difference was noted between the original and modified treatment groups (91.7% versus 90.7%, respectively, p = 0.824). Postoperatively, evolution of other urinary symptoms were similar in both groups. The incidence and intensity of groin pain was higher in the original TVT-O™ group on day 0 and day 1 (p = 0.003 and p = 0.011, respectively), but not the after, and patients in this group required more analgesics (p = 0.015). Concluding. 1-year follow-up, a modified version of the TVT-O™ procedure, with a shorther tape and reduced lateral dissection, was as safe and efficient as the original procedure for treating female SUI, and was associated with less postoperative groin pain.

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