Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder
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|ClinicalTrials.gov Identifier: NCT00912314|
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : August 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Procedure: PTNS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder|
|Actual Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Active Comparator: Monthly Maintenance PTNS
After 12 weeks of PTNS, patients will be randomized to either the monthly PTNS arm, or the no maintenance PTNS arm.
Monthly PTNS after 12 weeks of weekly PTNS
No Intervention: No maintenance PTNS
After 12 weeks of PTNS, patients will either be randomized to the Monthly PTNS arm or the No maintenance PTNS arm.
- time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not [ Time Frame: 40 weeks ]
- efficacy of a 12-week course of PTNS in the treatment of overactive bladder [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912314
|United States, California|
|UCSD Women's Pelvic Medicine Center|
|San Diego, California, United States, 92037|
|Principal Investigator:||Charles Nager, MD||UCSD|
|Study Director:||Anna C Kirby, MD||UCSD|