INTRODUCTION AND HYPOTHESIS: This trial aimed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse. METHODS: This multicenter randomized trial included 184 women, with POP-Q stage 3 or 4. They were randomly assigned to undergo surgical treatment using native tissue repair (n = 90) or synthetic mesh repair (n = 94). Native tissue repair surgery was performed according to site-specific defects, including sacrospinous ligament fixation for apical defects. Mesh repair (Prolift™) was performed in accordance with manufacturer recommendations. Hysterectomy was performed in all cases of uterine prolapse. Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up. We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length (TVL) after 1 year. The patients answered the Prolapse Quality-of-Life Questionnaire (PQoL) and the Sexual Quotient Female Version (QS-F) questionnaire. RESULTS: Both groups were homogeneous preoperatively. There were no differences between the groups in operative time, complications or pain. At 1-year follow-up, anatomical cure rates were better in the mesh group in the anterior compartment (p = 0.019). Significant improvement in PQoL scores at 1-year follow up were observed in each group; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group. CONCLUSION: Both techniques were effective. Anatomical efficacy was superior in the mesh group regarding the anterior compartment; quality of life changes were also greater in the mesh group. Complications were significantly higher in the mesh group.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: This trial aimed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse. METHODS: This multicenter randomized trial included 184 women, with POP-Q stage 3 or 4. They were randomly assigned to undergo surgical treatment using native tissue repair (n = 90) or synthetic mesh repair (n = 94). Native tissue repair surgery was performed according to site-specific defects, including sacrospinous ligament fixation for apical defects. Mesh repair (Prolift™) was performed in accordance with manufacturer recommendations. Hysterectomy was performed in all cases of uterine prolapse. Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up. We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length (TVL) after 1 year. The patients answered the Prolapse Quality-of-Life Questionnaire (PQoL) and the Sexual Quotient Female Version (QS-F) questionnaire. RESULTS: Both groups were homogeneous preoperatively. There were no differences between the groups in operative time, complications or pain. At 1-year follow-up, anatomical cure rates were better in the mesh group in the anterior compartment (p = 0.019). Significant improvement in PQoL scores at 1-year follow up were observed in each group; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group. CONCLUSION: Both techniques were effective. Anatomical efficacy was superior in the mesh group regarding the anterior compartment; quality of life changes were also greater in the mesh group. Complications were significantly higher in the mesh group.
Authors: Paulo Cezar Feldner; Rodrigo Aquino Castro; Luiz Antonio Cipolotti; Carlos Antonio Delroy; Marair Gracio Ferreira Sartori; Manoel João Batista Castello Girão Journal: Int Urogynecol J Date: 2010-04-29 Impact factor: 2.894
Authors: Fréderic Caquant; Pierre Collinet; Philippe Debodinance; Juan Berrocal; Olivier Garbin; Claude Rosenthal; Henri Clave; Richard Villet; Bernard Jacquetin; Michel Cosson Journal: J Obstet Gynaecol Res Date: 2008-08 Impact factor: 1.730
Authors: Guri Rortveit; Jeanette S Brown; David H Thom; Stephen K Van Den Eeden; Jennifer M Creasman; Leslee L Subak Journal: Obstet Gynecol Date: 2007-06 Impact factor: 7.661
Authors: Constantin M Durnea; Vasilios Pergialiotis; James M N Duffy; Lina Bergstrom; Abdullatif Elfituri; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2018-10-22 Impact factor: 2.894