Status:
COMPLETED
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Overactive Bladder
Urinary Urge Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
Eligibility Criteria
Inclusion
- Subjects 18 years of age or older
- Candidate for sacral neuromodulation in accordance with the InterStim System labeling
- Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
- Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Exclusion
- Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
- Have implantable pacemakers, or defibrillators
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
- Women who are pregnant or planning to become pregnant during participation in 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.
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04016324
Start Date
November 28 2019
End Date
October 9 2020
Last Update
November 23 2021
Active Locations (15)
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1
Pinellas Urology
St. Petersburg, Florida, United States, 33710
2
Florida Urology Partners
Tampa, Florida, United States, 33606
3
Minnesota Urology (Plymouth)
Plymouth, Minnesota, United States, 55441
4
Urologic Research and Consulting
Englewood, New Jersey, United States, 07631