Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
NCT ID: NCT01764893
Last Updated: 2014-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
8 participants
INTERVENTIONAL
2013-01-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PTNS and solifenacin
PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks
PTNS plus solifenacin
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.
PTNS and placebo
PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks
Placebo
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
Interventions
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PTNS plus solifenacin
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.
Placebo
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. history of overactive bladder
3. history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
4. PTNS-naive
5. willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
6. able to swallow and retain oral medication
7. able and willing to participate in the full duration of the study
8. able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
9. OAB-q (items 1-8) score of 30 or higher
Exclusion Criteria
2. history of urinary retention
3. history of gastric retention
4. uncontrolled narrow angle glaucoma
5. 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
6. 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
7. 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
8. known hypersensitivity to solifenacin
9. 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
10. pregnancy or trying to become pregnant
11. breast-feeding
18 Years
ALL
No
Sponsors
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Bay State Clinical Trials, Inc.
OTHER
Responsible Party
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Principal Investigators
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H. David Mitcheson, MD
Role: PRINCIPAL_INVESTIGATOR
Bay State Clinical Trials, Inc.
Locations
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Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Countries
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Other Identifiers
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BSU-SOL-001
Identifier Type: -
Identifier Source: org_study_id
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