Performance of the miniaturo™-I system for treatment of overactive bladder.
Completed
- Conditions
- rge incontinence caused by detrusor overactivity
- Registration Number
- NL-OMON23310
- Lead Sponsor
- American Medical Systems, Inc.10700 Bren Road WestMinnetonka, MN 55343 USATel: 952-930-6000Fax: 952-930-6007
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Females > 18 years;
2. Failed conservative treatment for > 6 mnths;
Exclusion Criteria
1. Participation in another study < 3 mnths;
2. Any active implant;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in number of leaking episodes/day.
- Secondary Outcome Measures
Name Time Method Clinical success rate at 3 months, 6 months and 12 months; number of serious adverse events.