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NCT00912314 · ClinicalTrials.gov registry record · NA
Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT00912314 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 11 participants.
The verdict
NCT00912314, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized, controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were successfully treated by PTNS in Part 1. Part 1: 12-week observational study of weekly PTNS treatment. The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the treatment of overactive bladder. Secondary aims are to determine the changes in voiding frequency and quality-of-life measures after the 12-week treatment. Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week treatment The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not, in order to ascertain if there is a need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to compare the long-term efficacy and quality of life impact in patient receiving maintenance PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS in subjects who have symptom recurrence in the no maintenance therapy arm. Hypothesis: There will be no difference in time to failure between women randomized to monthly maintenance PTNS compared to no maintenance PTNS.
Interventions
- PROCEDURE PTNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00912314
The ClinicalTrials.gov registry entry for NCT00912314 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PTNS is the first listed.
NCT00912314 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00912314 about?
NCT00912314 is a clinical study titled "Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder". This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized, controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were successfully treated by...
What is the current status of trial NCT00912314?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2009-02. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00912314?
The interventions under investigation include: PTNS (PROCEDURE).
Who is sponsoring clinical trial NCT00912314?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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