Clinical trial NCT01764893: Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Lead sponsor: Bay State Clinical Trials, Inc.
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overactive Bladder Questionnaire, items 1-8 only
timeFrame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
measure: Overactive Bladder Questionnaire, items 1-8 only
timeFrame: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
Secondary outcomes:
measure: 3-day micturition diary
timeFrame: Change in Bladder diary from Baseline to 5 weeks.
measure: 3-day micturition diary
timeFrame: Change in Bladder diary from Baseline to 11 weeks.
measure: 3-day micturition diary
timeFrame: Change in Bladder diary from Baseline to 15 weeks.
measure: Urgency Perception Scale (questionnaire)
timeFrame: Changes in Urgency Perception from Baseline to 11 weeks.
measure: Urgency Perception Scale (questionnaire)
timeFrame: Changes in Urgency Perception from Baseline to 15 weeks.
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
Study officials:
affiliation: Bay State Clinical Trials, Inc.
name: H. David Mitcheson, MD
role: PRINCIPAL_INVESTIGATOR
References: