Multicenter observational study for evaluation of patients satisfaction and cure rate after insertion of the MicroGYNious TVT from AMI
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00020588
- Lead Sponsor
- niversitätsklinikum Ulm, Kliniken am Michelsberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Female
- Target Recruitment
- 250
Inclusion Criteria
- all patients for whom the operation is indicated
- completion of the 18th year of life
- compliance regarding data collection, therapy and follow-up
Exclusion Criteria
- rigid urethra
- pregnancy
- OAB or mixed incontinence with predominant OAB
- state after Radiotherapy
- limited life expectancy / progressive malignant disease
- chronic pain syndrome, fibromyalgia, immune defects, connective tissue disorders
- intolerance to polypropylene
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient satisfaction after 2 years<br>Survey using the German pelvic floor questionnaire
- Secondary Outcome Measures
Name Time Method Secondary endpoints are:<br>• objective surgical result after 6 weeks, 6 months and every year up to 5 years postoperatively (cough test, residual urine, sonographic position of the tape)<br>• subjective satisfaction / quality of life after 6 weeks, 6 months and every year up to 5 years postoperatively (German pelvic floor questionnaire + incontinence questionnaire ICIQ-SF)<br>• postoperative painscore / the need of painmedication<br>• length of hospitalization<br>• complications: bladder or urethra injuries, revision surgery, bladder emptying disorder, hematoma