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.