Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans with Urinary Incontinence
- Conditions
- overactive bladder syndromeurinary incontinence (UI)10029903
- Registration Number
- NL-OMON44588
- Lead Sponsor
- euSpera Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• Patient must be eligible for treatment and indicated for the Medtronic InterStim® system or InterStim® II (implantable pulse generator and lead).
• Patient wishes to undergo an InterStim® or InterStim® II implant procedure after this acute study.
• Patient must be in good general health in the opinion of the Investigator.
• Patient is able to understand and has voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures.
• Patient must be minimum 18 years and maximum 65 years of age.
• Patient has any of the contraindications for the InterStim® system or InterStim® II system:
o Previous sacral surgery
o Neurological conditions
o Neurogenic bladder
o Neurogenic detrusor over activity
o Multiple Sclerosis
o Spinal cord injury
o Stress urinary incontinence
o Primary pelvic pain
o Pregnant as determined by urine pregnancy test during screening on the day of the procedure or plan to become pregnant
o Pelvic trauma
o Body Mass Index (BMI) below 18.5 or above 30
o Any other contraindication is left to the Investigator*s discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint 1:<br /><br>During the stimulation of the S3 sacral nerve, the investigation team will<br /><br>observe and record movements in the buttocks / natal cleft region and leg /<br /><br>foot region. This should include a bellows response in the pelvic floor along<br /><br>with a big toe (or other toe) flexion.<br /><br><br /><br>Primary Endpoint 2:<br /><br>Correct placement of the NSM AHLeveeS will be at the investigators discretion.<br /><br>After correct placement a fluoroscopy image will be obtained to capture the<br /><br>correct position.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoint:<br /><br>Time in minutes between the end of the stimulation protocol and the moment the<br /><br>NSM AHLeveeS System is explanted from the body.<br /><br><br /><br>Safety Endpoint:<br /><br>The safety endpoint has been selected due to the fact that this is a first in<br /><br>human study. It will be evaluated by: Recording all Adverse events, Device<br /><br>deficiency*s and Protocol Deviations and the need for additional surgical<br /><br>instruments.</p><br>