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NCT01009333 · ClinicalTrials.gov registry record · NA
InterStim Therapy Programming Study
A NA study of Urinary Urge Incontinence and Urgency Frequency, sponsored by MedtronicNeuro.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01009333: Completed NA study of Urinary Urge Incontinence and Urgency Frequency, sponsored by MedtronicNeuro.
NCT01009333 is a NA study of Urinary Urge Incontinence and Urgency Frequency that has completed, run by MedtronicNeuro. The registered enrollment target is 13 participants, below the 100-participant average among 6 other Urinary Urge Incontinence trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009333, a NA study of Urinary Urge Incontinence and Urgency Frequency, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE InterStim Therapy at rate 5.2 Hz
- DEVICE InterStim Therapy at rate 14 Hz
- DEVICE InterStim Therapy
Study Locations (1)
Michigan
- Kenneth Peters, MD - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-11 |
| Phase | NA |
What the finished NCT01009333 record still lists
NCT01009333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 100-participant average among 6 other Urinary Urge Incontinence trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Urinary Urge Incontinence appearing as the primary indexed condition, and to 3 interventions - of which InterStim Therapy at rate 5.2 Hz is the first listed.
NCT01009333 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01009333 about?
NCT01009333 is a clinical study titled "InterStim Therapy Programming Study". 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 r...
What is the current status of trial NCT01009333?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2009-11. Estimated completion is 2010-11.
What conditions does trial NCT01009333 study?
This clinical trial studies the following conditions: Urinary Urge Incontinence, Urgency Frequency.
What interventions are being tested in trial NCT01009333?
The interventions under investigation include: InterStim Therapy at rate 5.2 Hz (DEVICE), InterStim Therapy at rate 14 Hz (DEVICE), InterStim Therapy (DEVICE).
Who is sponsoring clinical trial NCT01009333?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01009333 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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