title: Transvaginal PVDF-mesh for cystocele repair: A cohort study.
abstract: BACKGROUND
  Optimized biocompatibility of new materials is a major requirement for transvaginal meshes for pelvic organ prolapse (POP) repair. Polyvinylidene fluoride (PVDF) presented good characteristics in prior animal experiments and clinical use in humans.
  
  
  METHODS
  Between 01/2012 and 04/2016 37 women underwent transvaginal repair of symptomatic prolapse of the anterior vaginal wall (cystocele) with PVDF-mesh in a single institution. A chart review for recurrence, continence, peri- and early postoperative complications was performed. Referring practitioners were interviewed by telephone and mail. Additionally patient reported outcome and satisfaction were measured by Patient Global Improvement Inventory (PGI-I) scale.
  
  
  RESULTS
  34 women were eligible for a mean follow up of 19 months. The functional outcome improved significantly. One symptomatic vault prolapse (2.9%) and two reoperations for incontinence (5.9%) occurred. Two mesh exposures (5.9%) occurred and were treated conservatively. No other severe complications were registered. 87.5% of treated women felt very much better or much better and would undergo the surgery again. A cohort study including development steps in accordance with the IDEAL system is presented.
  
  
  CONCLUSIONS
  For the first time we report on effectivity and safety of transvaginal application of PVDF-mesh in real-life practice. A prospective long-term evaluation in a registry is justified.
authors.affiliation: Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: dbarski@lukasneuss.de.
authors.forename: Dimitri
authors.initials: D
authors.lastname: Barski
authors.affiliation: Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: carndt@lukasneuss.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Arndt
authors.affiliation: University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Germany. Electronic address: holger.gerullis@gmx.net.
authors.forename: Holger
authors.initials: H
authors.lastname: Gerullis
authors.affiliation: Department of Urology, Affiliated Hospital of Chengdu University, Chengdu, China. Electronic address: 5458839@qq.com.
authors.forename: Jin
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Experimental Surgery, University of Szeged, Hungary. Electronic address: boros.mihaly@med.u-szeged.hu.
authors.forename: Mihaly
authors.initials: M
authors.lastname: Boros
authors.affiliation: Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: thomas_otto@lukasneuss.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Otto
authors.affiliation: Department of Gynecology, Marienhospital Bottrop, Germany. Electronic address: hans-christian.kolberg@mhb-bottrop.de.
authors.forename: Hans-Christian
authors.initials: HC
authors.lastname: Kolberg
mesh_terms: D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D015331:Cohort Studies; D020884:Colpotomy / Q000295:instrumentation / Q000379:methods; D052858:Cystocele / Q000601:surgery*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls; D011183:Postoperative Complications; D019736:Prostheses and Implants; D012086:Reoperation; D012189:Retrospective Studies; D013526:Surgical Mesh; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000601:surgery; D014621:Vagina / Q000601:surgery; D005465:Fluorocarbon Polymers
chemical_list: D001672:Biocompatible Materials; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers
keywords: Alloplastic material; Anterior mesh; Biocompatibility; Cystocele; IDEAL; Vaginal wall prolapse