InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

Completed · Not applicable

Conditions studied: Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome

In brief

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.

Key facts

Study ID

NCT04016324

Run by

MedtronicNeuro

People needed

110

Starts

2019-11-28

Expected to finish

2020-10-09

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pinellas Urology — St. Petersburg, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Minnesota Urology (Plymouth) — Plymouth, Minnesota, United States
• Urologic Research and Consulting — Englewood, New Jersey, United States
• FirstHealth Urogynecology — Hamlet, North Carolina, United States
• Wright State Physicians — Fairborn, Ohio, United States
• Prisma Health — Greenville, South Carolina, United States
• Southern Urogynecology — West Columbia, South Carolina, United States
• Urology Partners of North Texas — Arlington, Texas, United States
• Urology of Virginia — Virginia Beach, Virginia, United States
• University Urology Associates — Toronto, Ontario, Canada
• Radboud UMC — Nijmegen, Netherlands
• The Bristol Urological Institute — Bristol, United Kingdom
• The Newcastle upon Tyne Hospitals — Newcastle upon Tyne, United Kingdom
• Salford Royal NHS Foundation Trust — Salford, United Kingdom

Full record on ClinicalTrials.gov

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