title: Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center, Hugstetterstr. 55, 79106, Freiburg, Germany. juliane.farthmann@uniklinik-freiburg.de.
authors.forename: Juliane
authors.identifier: 0000-0002-8338-3531
authors.initials: J
authors.lastname: Farthmann
authors.affiliation: Department of Obstetrics and Gynecology, Klinikum Oberlausitzer Bergland, Zittau, Germany.
authors.forename: Mathias
authors.initials: M
authors.lastname: Mengel
authors.affiliation: Department of Obstetrics and Gynecology, St. Elisabeth-Krankenhaus, Leipzig, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Henne
authors.affiliation: Department of Obstetrics and Gynecology, Staedtisches Klinikum Friedrichstadt, Dresden, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Grebe
authors.affiliation: Department of Obstetrics and Gynecology, Evangelisches Diakoniekrankenhaus, Freiburg, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Watermann
authors.affiliation: Department of Obstetrics and Gynecology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Kaufhold
authors.affiliation: Department of Obstetrics and Gynecology, Klinik Tettnang, Tettnang, Germany.
authors.forename: Margit
authors.initials: M
authors.lastname: Stehle
authors.affiliation: Department of Obstetrics and Gynecology, Klinik Tettnang, Tettnang, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Fuenfgeld
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D052858:Cystocele / Q000601:surgery*; D004414:Dyspareunia / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D017773:Pelvic Floor / Q000503:physiopathology; D056887:Pelvic Organ Prolapse / Q000150:complications / Q000175:diagnosis* / Q000523:psychology / Q000601:surgery*; D011183:Postoperative Complications; D011184:Postoperative Period; D011446:Prospective Studies; D011788:Quality of Life; D012725:Sexual Behavior; D013526:Surgical Mesh / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014621:Vagina / Q000601:surgery
keywords: Alloplastic mesh; Dyspareunia; Pelvic organ prolapse; Quality of life; Sexual function