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

Lead Sponsor: Bay State Clinical Trials, Inc.

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.

• Overactive Bladder

Intervention Type: Other

Intervention Name: PTNS plus solifenacin

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: Placebo

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

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

United States

May 2014

Type: Sponsor

• Overactive Bladder

• Urinary Bladder, Overactive

Label: PTNS and solifenacin

Type: Active Comparator

Description: PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks

Label: PTNS and placebo

Type: Placebo Comparator

Description: PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)