A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder
Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
Sponsors
Source
Bay State Clinical Trials, Inc.
Oversight Info
Has Dmc
Yes
Brief Summary
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.
Overall Status
Terminated
Start Date
2013-01-01
Completion Date
2014-04-01
Primary Completion Date
2014-04-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
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
Measure |
Time Frame |
|
3-day micturition diary |
Change in Bladder diary from Baseline to 5 weeks. |
|
3-day micturition diary |
Change in Bladder diary from Baseline to 11 weeks. |
|
3-day micturition 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. |
Enrollment
8
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
PTNS and solifenacin
Other Name
Vesicare
Intervention Type
Other
Intervention Name
Description
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
Arm Group Label
PTNS and placebo
Eligibility
Criteria
Inclusion Criteria:
1. 18 years of age or older
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:
1. presence of cardiac pacemaker and/or defibrillator
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
H. David Mitcheson, MD |
Principal Investigator |
Bay State Clinical Trials, Inc. |
Location
Facility |
|
Bay State Clinical Trials, Inc. Watertown Massachusetts 02472 United States |
Location Countries
Country
United States
Verification Date
2014-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Solifenacin Succinate
Arm Group
Arm Group Label
PTNS and solifenacin
Arm Group Type
Active Comparator
Description
PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks
Arm Group Label
PTNS and placebo
Arm Group Type
Placebo Comparator
Description
PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks
Firstreceived Results Date
N/A
Why Stopped
Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous
Tibial Nerve Stimulation treatment.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
January 3, 2013
Study First Submitted Qc
January 8, 2013
Study First Posted
January 10, 2013
Last Update Submitted
May 22, 2014
Last Update Submitted Qc
May 22, 2014
Last Update Posted
May 23, 2014
Pending Results
Submitted
March 22, 2015
Returned
April 2, 2015
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.