NCT05226286
Completed
Not Applicable
Evaluation of Implantable Tibial Neuromodulation Pivotal Study
ConditionsOveractive Bladder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- MedtronicNeuro
- Enrollment
- 188
- Locations
- 29
- Primary Endpoint
- UUI Responder
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects 18 years of age or older
- •Qualifying voiding diary
- •Have a diagnosis of UUI for at least 6 months
- •Failed and/or are not a candidate for conservative therapies.
- •Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
Exclusion Criteria
- •Have primary stress incontinence
- •History of a prior implantable tibial neuromodulation system
- •Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
- •Previous pelvic floor surgery in the last 6 months
- •Women who are pregnant or planning to become pregnant during the course of the study
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
- •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
Outcomes
Primary Outcomes
UUI Responder
Time Frame: 6 months
Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant.
Secondary Outcomes
- UUI Change From Baseline(6 months)
- UF Change From Baseline(6 months)
- UPS Change at 6 Months(6 months)
- OAB-q Change From Baseline(6 months)
Study Sites (29)
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