Overactive Bladder
Conditions
Keywords
Overactive Bladder
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.
Interventions
OTHERPTNS 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.
OTHERPlacebo
12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
Sponsors
Bay State Clinical Trials, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overactive Bladder Questionnaire, items 1-8 only | Change from Baseline in Overactive Bladder Questionnaire at 11 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-day micturition diary | Change in Bladder diary from Baseline to 5 weeks. | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) |
| Urgency Perception Scale (questionnaire) | Changes in Urgency Perception from Baseline to 11 weeks. | — |
Countries
United States
Outcome results
None listed