CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
InterStim Therapy at rate 5.2 Hz +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01009333
NCT01009333N/ACompleted

InterStim Therapy Programming Study

MedtronicNeuro·interventional·Posted Nov 6, 2009·Updated May 27, 2013

In Brief

A clinical study evaluating InterStim Therapy at rate 5.2 Hz, InterStim Therapy at rate 14 Hz, and 1 other intervention for Urgency Frequency and Urinary Urge Incontinence. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2009
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.7 years ago

Interventions

InterStim Therapy at rate 5.2 Hzdevice

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

InterStim Therapy at rate 14 Hzdevice

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

InterStim Therapydevice

All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.