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

Phase 4

Terminated

• Conditions: Overactive Bladder
• Interventions: Other: PTNS plus solifenacin; Other: Placebo

• Registration Number: NCT01764893
• Lead Sponsor: Bay State Clinical Trials, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTNS and solifenacin	PTNS plus solifenacin	PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks
PTNS and placebo	Placebo	PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks

Primary Outcome Measures

Name	Time	Method
Overactive Bladder Questionnaire, items 1-8 only	Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.

Secondary Outcome Measures

Name	Time	Method
Urgency Perception Scale (questionnaire)	Changes in Urgency Perception from Baseline to 15 weeks.
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)

Trial Locations

Locations (1)

Bay State Clinical Trials, Inc.; 🇺🇸 Watertown, Massachusetts, United States