Loading clinical trials...

InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study | Clinical Trials | Clareo Health

COMPLETEDNA

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

InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study

NCT04016324•MedtronicNeuro

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects 18 years of age or older
•2. Candidate for sacral neuromodulation in accordance with the InterStim System labeling
•3. Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
•4. Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
•5. Willing and able to provide signed and dated informed consent

Exclusion Criteria

•1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
•2. Have implantable pacemakers, or defibrillators
•3. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
•4. 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
•5. Women who are pregnant or planning to become pregnant during participation in 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.

Locations (15)

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

Key Dates

Start Date

November 28, 2019

Primary Completion Date

October 6, 2020

Completion Date

October 9, 2020

Last Updated

November 23, 2021

Enrollment

110

ACTUAL participants

Conditions

Overactive BladderUrinary Urge IncontinenceUrgency-frequency Syndrome

Interventions

InterStim Basic Evaluation lead and foramen needle

DEVICE

TReating Incontinence for Underlying Mental and Physical Health

NCT05362292

Urinary Incontinence, UrgeUrinary Incontinence+4 more

View study

RECRUITINGNA

Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System

NCT07247136

Urinary Urge Incontinence

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

TReating Incontinence for Underlying Mental and Physical Health

Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System

INOPASE - Performance and Safety Study of a Personalised SNM System

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder