Evaluation of Implantable Tibial Neuromodulation Pivotal Study
- Conditions
- Overactive Bladder
- Registration Number
- NCT05226286
- Lead Sponsor
- MedtronicNeuro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 188
Inclusion Criteria:<br><br> 1. Subjects 18 years of age or older<br><br> 2. Qualifying voiding diary<br><br> 3. Have a diagnosis of UUI for at least 6 months<br><br> 4. Failed and/or are not a candidate for conservative therapies.<br><br> 5. Willing and able to accurately complete study diaries, questionnaires, attend<br> visits, operate the system, and comply with the study protocol<br><br> 6. Willing and able to provide signed and dated informed consent<br><br>Exclusion Criteria:<br><br> 1. Have primary stress incontinence<br><br> 2. History of a prior implantable tibial neuromodulation system<br><br> 3. Anatomical defects, clinically significant edema or previous surgeries which<br> precludes use of the device<br><br> 4. Previous pelvic floor surgery in the last 6 months<br><br> 5. Women who are pregnant or planning to become pregnant during the course of the study<br><br> 6. Characteristics indicating a poor understanding of the study or characteristics that<br> indicate the subject may have poor compliance with the study protocol requirements.<br><br> 7. Concurrent participation in another clinical study that may add additional safety<br> risks and/or confound study results.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome
- Secondary Outcome Measures
Name Time Method Secondary Objective;Secondary Objective;Secondary Objective;Secondary Objective