InterStim Therapy Programming Study

MedtronicNeuro1 site in 1 country13 target enrollmentNovember 2009

ConditionsUrgency Frequency Urinary Urge Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urgency Frequency
Sponsor: MedtronicNeuro
Enrollment: 13
Locations: 1
Primary Endpoint: Number of Urinary Incontinent Episodes Per Day
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

November 2010

Last Updated

12 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 in S2, S3, or S4
•Diagnosis before InterStim implant included urgency frequency (an average of 8 or more voids per day) and any amount of urinary urge incontinence over the voiding diary reporting period. The diary reporting period must be at least 2 days.
•Able to tolerate (ie, no complaint of pain or discomfort) acute high InterStim rate setting
•Able to tolerate (ie, no complaint of pain or discomfort) acute medium InterStim rate setting
•Able to tolerate (ie, no complaint of pain or discomfort) acute low InterStim rate setting
•Must be willing to maintain their current regimen (dosage and frequency) of any overactive bladder medication (anticholinergic or antimuscarinic) or tricyclic antidepression medication over the study duration
•Female subject 18 years of age or older
•Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study.
•Able to consent to participate by signing the Informed Consent Form

Exclusion Criteria

•Multiple sclerosis
•Reiter's syndrome
•Exclude diabetics unless the subject's diabetes is well-controlled with diet or medication
•History of spinal cord injury or a cerebral vascular accident (CVA)
•Active symptomatic urinary tract infection (UTI)
•Stress incontinence as the primary diagnosis
•Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/diagnosis
•Interstitial cystitis as the primary diagnosis
•Urinary retention as the primary diagnosis
•Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study

Outcomes

Primary Outcomes

Number of Urinary Incontinent Episodes Per Day

Time Frame: three weeks

In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.