Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series. (June 2017)

• Record Type: Journal Article
• Authors: Barski, Dimitri; Gerullis, Holger; Ecke, Thorsten; Kranz, Jennifer; Schneidewind, Laila; Leistner, Nadine; Queissert, Fabian; Mühlstädt, Sandra; Grabbert, Markus; Tahbaz, Rana; Pelzer, Alexandre Egon; Joukhadar, Ralf; Klinge, Uwe; Boros, Mihaly; Bader, Werner; Naumann, Gert; Puppe, Frank; Otto, Thomas
• Is Part Of: International journal of surgery. Volume 42(2017)
• Page Start: 27
• Page End: 33
• Publication Date: 2017-06
• Subjects: IDEAL -- Implant -- Incontinence -- Mesh -- Pelvic floor -- Prolapse -- Registry; Surgery -- Periodicals; Surgical Procedures, Operative -- Periodicals; 617.005
• DOI: 10.1016/j.ijsu.2017.04.028
• Languages: English
• ISSNs: 1743-9191

Abstract

Abstract: Introduction: Most aspects of implant-assisted reconstruction of pelvic floor in males and females are under debate and the research is not standardized. Registries are supposed to shed light to the indications, surgical techniques and material properties and to establish a standardized evaluation. Methods: A working group was formed to create an online platform for registration and outcome measurement of implant-assisted operations for pelvic organ prolapse (POP) and female and male stress urinary incontinence (SUI). 20 patients with modified mesh materials were evaluated over 23 months follow up in the registry to prove the feasibility of the registry. For validation a previously published modified "satisfaction, anatomy, continence, safety – S.(A.)C.S score" was used. Results: A consensus was met on definitions and classifications of patient variables, surgical procedures and implants, as well as outcome parameters (efficacy, continence, satisfaction, complications). Different subgroup modules were formed in accordance with treated condition. The maximum score of cure was reached by 25–100% of patients depending on the indication. Conclusion: A prospective registry in accordance with IDEAL-D framework is justified for the evaluation and regulation of implants for pelvic floor reconstruction. Highlights: A new web-based registry for the evaluation of implant assisted surgery for POP and SUI in males and females is presented. The presented case series show the feasibility of the registry with the need for indication based evaluation. The maximum score of cure was reached by 25–100% of patients depending on the indication. The preliminary results support the initiation of prospective registry according to IDEAL.