Prospective application observation to evaluate recurrences and surgical or postoperative complications in the context of surgical practice for the treatment of female and male stress incontinence and female pelvic floor prolapse with DynaMesh® mesh implants

Recruiting

Conditions: N81
N39.3
Stress incontinence
Female genital prolapse

Registration Number: DRKS00033613

Lead Sponsor: FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

Patients of legal age and legal capacity who will receive a corresponding DynaMesh® mesh implant due to surgical treatment of stress incontinence and/or pelvic floor prolapse with associated organ prolapse.

Exclusion Criteria

This is an observation of routine clinical practice, only patients who do not meet the inclusion criteria will be excluded.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study objective results from the new MDR requirements, with increased standards for post-market surveillance in the sense of a proactive post-market follow-up. The MDR (EU 2017/745) [Medical Device Regulation] calls on manufacturers to establish proactive and systematic procedures that make it possible to collect information about the safety and performance in routine use of medical devices that have already been placed on the market. The goals is to derive potentially necessary preventative and corrective measures.<br>The establishment of a uro-gynecological registry for systematically collecting data on safety and performance is the structural goal required by the MDR in the sense of a systematic PMCF

Secondary Outcome Measures

Name	Time	Method
The secondary objective is collecting the clinical data in the registry to be able to assess the clinical and technical safety and performance of the relevant devices after reclassification by the MDR and to systematically monitor the devices further.