Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder
Completed · Not applicable
Conditions studied: Overactive Bladder Syndrome
In brief
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.
Key facts
- Study ID
- NCT00912314
- Run by
- University of California, San Diego
- People needed
- 11
- Starts
- 2009-02-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2019-08-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women with refractory overactive bladder syndrome referred to UCSD Women's Pelvic Medicine Center by treating physician for PTNS therapy as standard of care
- At least 18 years old
- 9 or more voids per 24 hours
- PGI - S score of "moderate" or "great" bother
- If on anticholinergic medication, they must be on stable dose of medications for at least one month
- Able to provide informed consent and complete study measures
You may not qualify if…
- Postvoid residual > 150 ml to exclude subjects with urinary retention
- Active urinary tract infection (defer entry until resolved)
- Urine output > 2800 ml per day
- Diagnosis of interstitial cystitis or chronic pelvic pain
- Diagnosis of bladder cancer
- Currently pregnant
Where it is running
- UCSD Women's Pelvic Medicine Center — San Diego, California, United States
Full record on ClinicalTrials.gov
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