Evaluation of Implantable Tibial Neuromodulation Pivotal Study
Purpose
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
Condition
- Overactive Bladder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects 18 years of age or older 2. Qualifying voiding diary 3. Have a diagnosis of UUI for at least 6 months 4. Failed and/or are not a candidate for conservative therapies. 5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol 6. Willing and able to provide signed and dated informed consent
Exclusion Criteria
- Have primary stress incontinence 2. History of a prior implantable tibial neuromodulation system 3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 4. Previous pelvic floor surgery in the last 6 months 5. Women who are pregnant or planning to become pregnant during the course of the study 6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
More Details
- Status
- Active, not recruiting
- Sponsor
- MedtronicNeuro