Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence
Phase 1
Completed
- Conditions
- Overactive Bladder
- Interventions
- Device: AHLeveeS System
- Registration Number
- NCT03643380
- Lead Sponsor
- Neuspera Medical, Inc.
- Brief Summary
A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
- Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
- Subject was in good health in the opinion of the investigator
- Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
- Subject was minimum of 18 years and maximum of 65 years of age
Exclusion Criteria
- Subject had any of the contraindications for the InterStim system or InterStim II system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational SNS device AHLeveeS System -
- Primary Outcome Measures
Name Time Method Sacral Nerve Response measured by observed bellow response and big toe flexion Procedure Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion
AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image Procedure Confirm that the AHLeveeS System can be correctly placed and inserted in close proximity of the sacral nerve in the S3 foramina assessed by fluoroscopy image
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Netherlands