Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up.

OBJECTIVE: To compare the long-term efficacy of laparoscopic Burch colposuspension with tension-free vaginal tape (TVT) for the treatment of urodynamic stress urinary incontinence (SUI).

DESIGN: Long-term follow up from a prospective randomised trial.

SETTING: Academic tertiary referral centre.

SAMPLE: Seventy-two women with urodynamic SUI from two institutions.

METHODS: Subjects were randomised to either laparoscopic Burch or TVT from August 1999 to August 2002. Follow-up evaluations occurred 6 months, 1 year, 2 years, and 4-8 years after surgery.

MAIN OUTCOME MEASURES: Subjects completed the Incontinence Severity Index, Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Patient Global Impression of Improvement (PGI-I) scales.

RESULTS: Median follow-up duration was 65 months (range 12-88 months) with 92% completing at least one follow-up visit. Seventy-four percent of subjects had long-term (4-8 years) follow up. Fifty-eight percent of subjects receiving laparoscopic Burch compared with 48% of TVT subjects reported any urinary incontinence 4-8 years after surgery (Relative Risk (RR):1.19; 95% CI: 0.71-2.0) with no significant difference between groups. Bothersome SUI symptoms were seen in 11 and 8%, respectively, 4-8 years after surgery (P = 0.26). There was significant improvement in the postoperative UDI-6 and IIQ-7 scores in both groups at 1-2 years that were maintained throughout follow up with no significant differences between the groups.

CONCLUSIONS: TVT has similar long-term efficacy to laparoscopic Burch for the treatment of SUI. A substantial proportion of subjects have some degree of urinary incontinence 4-8 years after surgery; however, the majority of incontinence is not bothersome.