Dimitri Barski1, Christian Arndt2, Holger Gerullis3, Jin Yang4, Mihaly Boros5, Thomas Otto6, Hans-Christian Kolberg7. 1. Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: dbarski@lukasneuss.de. 2. Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: carndt@lukasneuss.de. 3. University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University Oldenburg, Germany. Electronic address: holger.gerullis@gmx.net. 4. Department of Urology, Affiliated Hospital of Chengdu University, Chengdu, China. Electronic address: 5458839@qq.com. 5. Department of Experimental Surgery, University of Szeged, Hungary. Electronic address: boros.mihaly@med.u-szeged.hu. 6. Department of Urology, Lukas Hospital, Neuss, Germany. Electronic address: thomas_otto@lukasneuss.de. 7. Department of Gynecology, Marienhospital Bottrop, Germany. Electronic address: hans-christian.kolberg@mhb-bottrop.de.
Abstract
INTRODUCTION: 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.
INTRODUCTION: 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: Roxanna E Abhari; Matthew L Izett-Kay; Hayley L Morris; Rufus Cartwright; Sarah J B Snelling Journal: Nat Rev Urol Date: 2021-09-20 Impact factor: 14.432
Authors: Carl J Heneghan; Ben Goldacre; Igho Onakpoya; Jeffrey K Aronson; Tom Jefferson; Annette Pluddemann; Kamal R Mahtani Journal: BMJ Open Date: 2017-12-06 Impact factor: 2.692