Application observation on quality of life and cohabitation problems in patients with the suburethral PVDF band DynaMesh®-SIS (soft)

Recruiting

Conditions: N39.3
Stress incontinence

Registration Number: DRKS00033888

Lead Sponsor: FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

all patients who agree to data collection
- all patients treated with the surgical procedure using the DynaMesh-SIS band
- all patients who are legally competent and mentally capable of completing the questionnaires

Exclusion Criteria

-As this is an observation of routine clinical practice, no patients meeting the inclusion criteria will be excluded
-Previously operated patients with a mesh product

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study aim is the subjective change in quality of life and cohabitation problems before and after the surgical treatment of stress urinary incontinence. For this purpose, the condition before the operation and 3, 12 and 36 months after the operation is recorded and compared using validated patient questionnaires (ICIQ-OAB, ICIQ-UI-SF) and a self-created questionnaire.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives include recording potential mesh-related complications with/without reoperation or other treatment-related issues. These data can assess the clinical and technical safety and performance of the relevant products after reclassification by the MDR (EU 2017/745) [Medical Devices Regulation] and can be systematically monitored further.