Status:
COMPLETED
Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder
Lead Sponsor:
University of California, San Diego
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 tria...
Detailed Description
This study has two parts: an observational study of PTNS (Part 1) and a randomized, controlled trial of maintenance PTNS compared to no maintenance PTNS (Part 2). Part 1: This is an observational stu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00912314
Start Date
February 1 2009
End Date
June 1 2010
Last Update
August 2 2019
Active Locations (1)
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1
UCSD Women's Pelvic Medicine Center
San Diego, California, United States, 92037