Pelvicol pubovaginal sling versus tension-free vaginal tape for treatment of urodynamic stress incontinence: a prospective randomized three-year follow-up study.

OBJECTIVES

The aim of this study was to compare the long-term success rates, complication rates and patient satisfaction rates for Pelvicol pubovaginal sling (Bard) versus TVT (Gynecare) in surgical treatment of urodynamic stress incontinence (USI) in women.

DESIGN

Prospective randomized cohort trial.

SETTING

District General Hospital, South West of England.

METHODS

One hundred and forty-two women with urodynamic stress incontinence were randomized to either surgical procedure (Pelvicol = 74, TVT = 68) with median follow-up of 36 month. A postal questionnaire was sent to all women and the response rate was excellent at approximately 90% in both groups.

RESULTS

Cure of incontinence, as identified by a quality of life improvement >90%, and/or patient-determined continent status as dry, were comparable in both groups. When the cure rates were adjusted assuming the non-respondents as failures the figures were almost identical (p > 0.05). Preoperative continence pad usage was similar for both groups. Overall, a postoperative significant decrease in pad score was noted in both groups (p = 0.01) but there was no significant difference between the groups (p > 0.05). Statistical analysis failed to detect significant differences between both groups as regards complication rates such as frequency, nocturia, de-novo urgency or dyspareunia.

CONCLUSION

Pelvicol sling is a safe procedure in the surgical management of USI with similar success rate and patient satisfaction rate to TVT up to three years of follow-up.