Prospective registry study to evaluate recurrences and complications after surgical treatment of male stress incontinence with DynaMesh®-PRM mesh implants
Recruiting
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00032228
- Lead Sponsor
- FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
The informed consent form has been signed by the patient after verbal and written explanation for participation in the registry study.
Exclusion Criteria
Pre-operated patients with surgical incontinence therapies.
Since this is an observation of routine clinical practice, no further exclusion criteria are defined.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary purpose of this registry study is to assess the performance of the product. Performance parameter here is:<br>• Reoperation for recurrent or persistent incontinence.<br>• Correction of incontinence (based on daily use of pads, urine leakage 24h pad test)<br>• improvement of incontinence severity (according to ICS classification: light/medium/severe*)<br>• the question: I would have the operation again.<br>• the question: has the quality of life improved with regard to incontinence symptoms?<br>* light: 1.3-20 g, moderate: 21-74 g, heavy: > 75 g in the 24-h pad test (https://pubmed.ncbi.nlm.nih.gov/15270937/)<br>The primary endpoint is the frequency of recurrent or persistent stress urinary incontinence.<br>For this purpose, the patients will carry out a pad test/24h and fill out QoL questionnaires. The times of the pad test and the completion of the questionnaires are before the operation and after 6-8 weeks, 6 months and after 1, 3, 5, 10, 15 years<br>
- Secondary Outcome Measures
Name Time Method The secondary endpoints are used to assess the safety of the product:<br>• Intraoperative complications<br>• Bleeding (> 200 ml)<br>• Lesion of adjacent structures<br>• Postoperative complications<br>• Hematuria<br>• Hematoma<br>• Erosion<br>• Fistula formation<br>• Dislocation<br>• Pain- postoperative (< 3months)<br>• Pain chronic (> 3 months)<br>• de novo micturition disorders<br>• de novo urge incontinence<br>• Infection of the wound<br>• Infection of the implant<br>• urinary tract infections<br>• paresthesia<br>• Re-operation due to complications<br>• Position of the implant (centric alignment, fold-free adaptation to the bulb, fixation) as well as the associated positional correction of related anatomical structures (urethra) (MRI sub-study only)<br>