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.
RCT Entities:
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.
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