Overactive Bladder
Conditions
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.
Interventions
DEVICEAHLeveeS System
AHLeveeS System for treatment of overactive bladder
Sponsors
Neuspera Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed