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CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
MULTICENTER STUDY
[Safety and 12-month results on stage 3-4 cystocele repair by the vaginal route using a light-weight mesh].
Progrès en Urologie 2013 April
OBJECTIVE: To assess safety and efficacy at short-term of a light-weight polypropylene mesh (28 g/m2) for stage 3-4 cystocele repair by the vaginal route.
MATERIAL AND METHODS: A multicentric prospective cohort study, performed between 2010 and 2011 in seven centers. Pre-operative assessment included prolapse quantification using the POP-Q. Pre- and postoperative validated symptoms and quality of life questionnaires were used. Main objective was mesh safety. Secondary objectives were anatomical and functional success.
RESULTS: One hundred and eleven patients, with a mean age of 67±9 years, were included in the study, and 94 were included in the analysis (84.7%). In 14 cases (12.8%), it was a secondary surgery. Two intra-operative complications occurred (2.2%). Safety analysis on 86 patients followed up at 12 months (91.5%) has shown satisfaction rate of 98.8% (85/86), mesh contraction rate of 9.3% (8/86), one case of vaginal mesh exposure (1.2%), no cases of pelvic pain and rate of postoperative dyspareunia of 5.5% (3/55). Anatomic success rate on cystocele (Ba point < -1) at short-term was 82/86 (95.3%) and improvement of symptoms and quality of life was highly significant. Five patients (5.3%) were reoperated.
CONCLUSION: Cystocele repair by the vaginal route using a light-weight transobturator polypropylene mesh was safe and efficient at short-term. Long-term data are needed.
MATERIAL AND METHODS: A multicentric prospective cohort study, performed between 2010 and 2011 in seven centers. Pre-operative assessment included prolapse quantification using the POP-Q. Pre- and postoperative validated symptoms and quality of life questionnaires were used. Main objective was mesh safety. Secondary objectives were anatomical and functional success.
RESULTS: One hundred and eleven patients, with a mean age of 67±9 years, were included in the study, and 94 were included in the analysis (84.7%). In 14 cases (12.8%), it was a secondary surgery. Two intra-operative complications occurred (2.2%). Safety analysis on 86 patients followed up at 12 months (91.5%) has shown satisfaction rate of 98.8% (85/86), mesh contraction rate of 9.3% (8/86), one case of vaginal mesh exposure (1.2%), no cases of pelvic pain and rate of postoperative dyspareunia of 5.5% (3/55). Anatomic success rate on cystocele (Ba point < -1) at short-term was 82/86 (95.3%) and improvement of symptoms and quality of life was highly significant. Five patients (5.3%) were reoperated.
CONCLUSION: Cystocele repair by the vaginal route using a light-weight transobturator polypropylene mesh was safe and efficient at short-term. Long-term data are needed.
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