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.

AttachmentSize
Скачать статью571 KB