InterStim® Sacral Nerve Modulation Cycling Study

MedtronicNeuro3 sites in 1 country30 target enrollmentSeptember 2013

ConditionsUrinary Urge Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Urge Incontinence
Sponsor: MedtronicNeuro
Enrollment: 30
Locations: 3
Primary Endpoint: Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

November 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months
•Implanted with tined lead models 3889 or 3093
•Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy
•Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator
•Primary diagnosis before InterStim implant is urinary urge incontinence.
•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.
•Female subject 18 years of age or older
•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
•Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization
•Able to consent to participate by signing the Informed Consent Form

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion

Time Frame: 4 weeks

Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.