Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: PTNS plus solifenacin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTNS and solifenacin<br>PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks | Other: PTNS plus solifenacin<br>* 12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug.<br>* Other names: Vesicare;|
| Placebo Comparator: PTNS and placebo<br>PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks | Other: Placebo<br>* 12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Questionnaire, items 1-8 only |  | Change from Baseline in Overactive Bladder Questionnaire at 11 weeks. | 
| Overactive Bladder Questionnaire, items 1-8 only |  | Change from Baseline in Overactive Bladder Questionnaire at 15 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-day micturition diary | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) | Change in Bladder diary from Baseline to 5 weeks. | 
| 3-day micturition diary | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) | Change in Bladder diary from Baseline to 11 weeks. | 
| 3-day micturition diary | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) | Change in Bladder diary from Baseline to 15 weeks. | 
| Urgency Perception Scale (questionnaire) |  | Changes in Urgency Perception from Baseline to 11 weeks. | 
| Urgency Perception Scale (questionnaire) |  | Changes in Urgency Perception from Baseline to 15 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder