Juliane Farthmann1, Mathias Mengel2, Birgit Henne3, Markus Grebe4, Dirk Watermann5, Jan Kaufhold6, Margit Stehle7, Christian Fuenfgeld7. 1. Department of Obstetrics and Gynecology, University Medical Center, Hugstetterstr. 55, 79106, Freiburg, Germany. juliane.farthmann@uniklinik-freiburg.de. 2. Department of Obstetrics and Gynecology, Klinikum Oberlausitzer Bergland, Zittau, Germany. 3. Department of Obstetrics and Gynecology, St. Elisabeth-Krankenhaus, Leipzig, Germany. 4. Department of Obstetrics and Gynecology, Staedtisches Klinikum Friedrichstadt, Dresden, Germany. 5. Department of Obstetrics and Gynecology, Evangelisches Diakoniekrankenhaus, Freiburg, Germany. 6. Department of Obstetrics and Gynecology, Klinikum Ludwigsburg, Ludwigsburg, Germany. 7. Department of Obstetrics and Gynecology, Klinik Tettnang, Tettnang, Germany.
Abstract
PURPOSE: Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year. METHODS: 289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP(®) Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test. RESULTS: The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p < 0.001). Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up. CONCLUSIONS: In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery.
PURPOSE: Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year. METHODS: 289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP(®) Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test. RESULTS: The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p < 0.001). Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up. CONCLUSIONS: In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery.
Entities:
Keywords:
Alloplastic mesh; Dyspareunia; Pelvic organ prolapse; Quality of life; Sexual function
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