Prospective multicentric observational study for surgical treatment of stress urinary incontinence with a suburethral polypropylen tape (NEOMEDIC KIM)
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00007614
- Lead Sponsor
- eomedic International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Female
- Target Recruitment
- 143
1) patients with complicated and non- complicated stress incontinence, who need surgical treatment
2) patients from age of 18 years
3) fullfilled family planing
4) cooperation for data collection, therapy and follow-up investigations
5) patient information was delivered and written consent is present
6) urodynamics are obligatory in case of complicated stress incontinence (e.g. previous incontinence operation, neurologic symptoms, mixed incontinence)
7) obligatory single shot antibiotics pre-/ peroperatively
1) pregnancy
2) simultaneous prolapse surgery
3) prolapse of uterus or vagina > POP-Q II
4) known imcompatibility of the implant
5) immobile urethra
6) no previous urodynamic investigation in case of complicated stress incontinence (see inclusion criterion)
7) state after radiation in true pelvis
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method