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

• Sponsor: Bay State Clinical Trials, Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01764893
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Other: PTNS plus solifenacin; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PTNS and solifenacin PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks	Other: 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.; Other Names: Vesicare
Placebo Comparator: PTNS and placebo PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Overactive Bladder Questionnaire, items 1-8 only [Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.]

2. Overactive Bladder Questionnaire, items 1-8 only [Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.]

Secondary Outcome Measures

1. 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)

2. 3-day micturition diary [Change in Bladder diary from Baseline to 11 weeks.]

   To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

3. 3-day micturition diary [Change in Bladder diary from Baseline to 15 weeks.]

   To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)

4. Urgency Perception Scale (questionnaire) [Changes in Urgency Perception from Baseline to 11 weeks.]

5. Urgency Perception Scale (questionnaire) [Changes in Urgency Perception from Baseline to 15 weeks.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bay State Clinical Trials, Inc.	Watertown	Massachusetts	United States	02472

Sponsors and Collaborators

• Bay State Clinical Trials, Inc.

Investigators

• Principal Investigator: H. David Mitcheson, MD, Bay State Clinical Trials, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bay State Clinical Trials, Inc.
• ClinicalTrials.gov Identifier: NCT01764893
• Other Study ID Numbers: BSU-SOL-001
• First Posted: Jan 10, 2013
• Last Update Posted: May 23, 2014
• Last Verified: May 1, 2014

• Keywords provided by Bay State Clinical Trials, Inc.: Overactive Bladder
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Solifenacin Succinate

Study Results

No Results Posted as of May 23, 2014