OBJECTIVE: To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). DESIGN: A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD. SETTING:Tertiary referral urogynaecology unit in Australia. POPULATION: Women with SUI and ISD who were suitable for either surgical technique. METHODS:Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling (n = 22) or transurethral Macroplastique (n = 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43-71). MAIN OUTCOME MEASURE: Comparison of success rates, complications and costs. RESULTS: The symptomatic and patient satisfaction success rates were similar following the sling and Macroplastique with the objective success rate being significantly greater (P < 0.001) following the sling (81%vs 9%). Macroplastique had significantly lower morbidity but was more expensive than the sling (P < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69%vs 21%) and satisfaction rates (69%vs 29%, P = 0.057). CONCLUSIONS: The pubovaginal sling was more effective and economical than transurethral Macroplastique for the treatment of SUI and ISD. However, transurethral Macroplastique remains an appropriate treatment in selected cases of SUI and ISD.
RCT Entities:
OBJECTIVE: To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). DESIGN: A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD. SETTING: Tertiary referral urogynaecology unit in Australia. POPULATION: Women with SUI and ISD who were suitable for either surgical technique. METHODS: Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling (n = 22) or transurethral Macroplastique (n = 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43-71). MAIN OUTCOME MEASURE: Comparison of success rates, complications and costs. RESULTS: The symptomatic and patient satisfaction success rates were similar following the sling and Macroplastique with the objective success rate being significantly greater (P < 0.001) following the sling (81%vs 9%). Macroplastique had significantly lower morbidity but was more expensive than the sling (P < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69%vs 21%) and satisfaction rates (69%vs 29%, P = 0.057). CONCLUSIONS: The pubovaginal sling was more effective and economical than transurethral Macroplastique for the treatment of SUI and ISD. However, transurethral Macroplastique remains an appropriate treatment in selected cases of SUI and ISD.
Authors: Vivienne Kirchin; Tobias Page; Phil E Keegan; Kofi Om Atiemo; June D Cody; Samuel McClinton; Patricia Aluko Journal: Cochrane Database Syst Rev Date: 2017-07-25