Lucie Allègre1, Geertje Callewaert2,3,4, Sandrine Alonso5, Arnaud Cornille6, Hervé Fernandez7, Georges Eglin8, Renaud de Tayrac1. 1. Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France. 2. Department of Obstetrics and Gynecology, CHU Nîmes, University of Montpellier, Nîmes, France. geertje.callewaert@chu-nimes.fr. 3. Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium. geertje.callewaert@chu-nimes.fr. 4. Department of Obstetrics and Gynecology, Nîmes University Hospital, Place du Pr Debré, 30029, Nîmes Cedex 9, France. geertje.callewaert@chu-nimes.fr. 5. Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, University of Montpellier, Nîmes, France. 6. Department of Obstetrics and Gynecology, Clinique Beau Soleil, Montpellier, France. 7. Department of Obstetrics and Gynecology, Kremin Bicêtre Hospital, Kremin Bicêtre, France. 8. Department of Obstetrics and Gynecology, Clinique Champeau, Béziers, France.
Abstract
INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparinganterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The aim of this study was to report the long-term subjective and objective outcomes after transvaginal mesh (TVM) or native tissue repair. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009 comparing anterior colporrhaphy with trans-obturator vaginal mesh (Pelvitex/Ugytex®, Sofradim, Trevoux, France) for the treatment of anterior vaginal wall prolapse. The primary endpoint was functional recurrence rate 5-8 years after surgery. Secondary endpoints consisted of anatomical results, mesh-related morbidity and patient satisfaction measured through validated questionnaires. RESULTS: Of the 147 women originally included, 75 (51%) were successfully re-contacted a median of 7 years after the initial surgery. The primary outcome, subjective recurrence of prolapse, was similar between the TVM and the anterior colporrhaphy groups (31 vs 34% respectively). Anatomical recurrence was less likely in the TVM group (67 vs 24%, p = 0.004). Mesh exposure occurred in 4 of the 39 patients (13%) during follow-up, 2 of which had a surgical reintervention. Reintervention for prolapse took place in 7 patients (9%). CONCLUSION: Seven-year follow-up showed similar functional outcomes for mesh and native tissue repair in anterior vaginal wall prolapse. TVM did not reduce repeat surgery in the long term; it did, however, reduce anatomical recurrence. Mesh exposure rates were relatively high, but no difference in outcome of pain or dyspareunia was noted.
Entities:
Keywords:
Anterior colporrhaphy; Cystocele; Long-term outcome; Pelvic organ prolapse; Polypropylene mesh; Vaginal surgery
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