Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Overactive Bladder
In brief
The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.
Key facts
- Study ID
- NCT01764893
- Run by
- Bay State Clinical Trials, Inc.
- People needed
- 8
- Starts
- 2013-01-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2014-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- history of overactive bladder
- history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
- PTNS-naive
- willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
- able to swallow and retain oral medication
- able and willing to participate in the full duration of the study
- able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
- OAB-q (items 1-8) score of 30 or higher
You may not qualify if…
- presence of cardiac pacemaker and/or defibrillator
- history of urinary retention
- history of gastric retention
- uncontrolled narrow angle glaucoma
- any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
- abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin > 3 times the upper limit of normal
- history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- known hypersensitivity to solifenacin
- participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period
- pregnancy or trying to become pregnant
- breast-feeding
Where it is running
- Bay State Clinical Trials, Inc. — Watertown, Massachusetts, United States
Full record on ClinicalTrials.gov
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