M I Withagen1, A L Milani, J W de Leeuw, M E Vierhout. 1. Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. m.withagen@obgyn.umcn.nl
Abstract
OBJECTIVE: To compare the de novo prolapse rate in the untreated vaginal compartments following conventional vaginal prolapse repair and tension-free vaginal mesh repair. DESIGN: Secondary analysis of a randomised controlled trial. SETTING:Thirteen centres in the Netherlands. POPULATION: Women with recurrent pelvic organ prolapse stage II or higher. METHODS: Random assignment to either conventional vaginal native tissue repair or vaginal mesh insertion. PRIMARY OUTCOME: de novo pelvic organ prolapse stage II or higher in the untreated vaginal compartments at 12 months after surgery. SECONDARY OUTCOMES: de novo pelvic organ prolapse at and beyond the hymen, de novo prolapse beyond the hymen and prolapse domain scores of the Urogenital Distress Inventory. RESULTS: At 12 months ten of 59 women (17%) in the conventional group versus 29 of 62 women (47%) in the mesh group were diagnosed with a de novo pelvic organ prolapse stage II or higher in the untreated compartment (P < 0.001, odds ratio 4.3, 95% confidence interval 1.9-10.0). Additional apical support to a mesh-augmented anterior repair significantly reduced the de novo prolapse rate. Women with a de novo prolapse in the mesh-treated group demonstrated significantly higher mean bother scores on the domain genital prolapse of the Urogenital Distress Inventory score (13.1 ± 24.2) compared with those without de novo prolapse (2.9 ± 13.9) (P = 0.03). CONCLUSION:Mesh-augmented prolapse repair in only one vaginal compartment is associated with a higher de novo prolapse rate in the untreated compartments compared with conventional vaginal native tissue repair in women with recurrent pelvic organ prolapse.
RCT Entities:
OBJECTIVE: To compare the de novo prolapse rate in the untreated vaginal compartments following conventional vaginal prolapse repair and tension-free vaginal mesh repair. DESIGN: Secondary analysis of a randomised controlled trial. SETTING: Thirteen centres in the Netherlands. POPULATION: Women with recurrent pelvic organ prolapse stage II or higher. METHODS: Random assignment to either conventional vaginal native tissue repair or vaginal mesh insertion. PRIMARY OUTCOME: de novo pelvic organ prolapse stage II or higher in the untreated vaginal compartments at 12 months after surgery. SECONDARY OUTCOMES: de novo pelvic organ prolapse at and beyond the hymen, de novo prolapse beyond the hymen and prolapse domain scores of the Urogenital Distress Inventory. RESULTS: At 12 months ten of 59 women (17%) in the conventional group versus 29 of 62 women (47%) in the mesh group were diagnosed with a de novo pelvic organ prolapse stage II or higher in the untreated compartment (P < 0.001, odds ratio 4.3, 95% confidence interval 1.9-10.0). Additional apical support to a mesh-augmented anterior repair significantly reduced the de novo prolapse rate. Women with a de novo prolapse in the mesh-treated group demonstrated significantly higher mean bother scores on the domain genital prolapse of the Urogenital Distress Inventory score (13.1 ± 24.2) compared with those without de novo prolapse (2.9 ± 13.9) (P = 0.03). CONCLUSION: Mesh-augmented prolapse repair in only one vaginal compartment is associated with a higher de novo prolapse rate in the untreated compartments compared with conventional vaginal native tissue repair in women with recurrent pelvic organ prolapse.
Authors: Daniel Altman; Tomi S Mikkola; Karl Möller Bek; Päivi Rahkola-Soisalo; Jonas Gunnarsson; Marie Ellström Engh; Christian Falconer Journal: Int Urogynecol J Date: 2016-02-13 Impact factor: 2.894