N39.3
Conditions
Interventions
Group 1: Patients with stress incontinence caused by a hypermobile urethra and/or an intrinsic sphincter deficiency and who are treated with the surgical procedure (retropubic or transobturator) using
Sponsors
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactUlrich Füllers
Gynäkologische Tagesklinik GbR
Outcome results
None listed