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InterStim® Sacral Nerve Modulation Cycling Study | Clinical Trials | Clareo Health

COMPLETEDNA

InterStim® Sacral Nerve Modulation Cycling Study

NCT01957137•MedtronicNeuro

View on ClinicalTrials.gov

Summary

The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.

Detailed Description

This feasibility study will assess the following outcomes: * Voiding diaries * Patient reported assessments of response or satisfaction * Adverse events

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months
•2. Implanted with tined lead models 3889 or 3093
•3. Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy
•4. Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator
•5. Primary diagnosis before InterStim implant is urinary urge incontinence.
•6. Must be willing to maintain her current regimen (dosage and frequency) of any overactive bladder (OAB) medication (anticholinergic, antimuscarinic or Myrbetriq (Mirabegron)) or tricyclic antidepression medication over the study duration, if applicable.
•7. Female subject 18 years of age or older
•8. Willing and able to accurately complete voiding diaries and questionnaires, attend visits (within the visit windows +7 days), and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study
•9. Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization
•10. Able to consent to participate by signing the Informed Consent Form

Exclusion Criteria

•11. History of Multiple sclerosis
•12. History of Reiter's syndrome
•13. History of spinal cord injury or a cerebral vascular accident (CVA)
•14. History of diabetes unless the diabetes is well-controlled through diet and/or medications
•15. Active symptomatic urinary tract infection (UTI)
•16. Stress incontinence as the primary diagnosis
•17. Urgency frequency as a primary diagnosis
•18. Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis
•19. Interstitial cystitis as the primary diagnosis
•20. Urinary retention as the primary diagnosis
+9 more criteria

Locations (3)

Pinellas Urology, Inc.

St. Petersburg, Florida, United States

University of Iowa Healthcare

Iowa City, Iowa, United States

Metro Urology

Woodbury, Minnesota, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

December 12, 2017

Enrollment

ACTUAL participants

Conditions

Urinary Urge Incontinence

Interventions

InterStim® (Device Programming)

DEVICE

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

NCT07247136

Urinary Urge Incontinence

View study

ACTIVE_NOT_RECRUITINGNA

F15 Recharge Free Axonics SNM System Clinical Study

NCT06186765

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)+1 more

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: December 12, 2017Data 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.

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InterStim® Sacral Nerve Modulation Cycling Study

Inclusion Criteria

Exclusion Criteria

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

F15 Recharge Free Axonics SNM System Clinical Study

Bladder Diary for Female Storage LUTS

The Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence

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

Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology