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Clinical Trials/NCT01764893
NCT01764893TerminatedPhase 4

A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder

Bay State Clinical Trials, Inc.1 site in 1 country8 target enrollmentStarted: January 1, 2013Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
8
Locations
1
Primary Endpoint
Overactive Bladder Questionnaire, items 1-8 only
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 years of age or older
  • •history of overactive bladder
  • •history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
  • •willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
  • •able to swallow and retain oral medication
  • •able and willing to participate in the full duration of the study
  • •able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
  • •OAB-q (items 1-8) score of 30 or higher

Exclusion Criteria

  • •presence of cardiac pacemaker and/or defibrillator
  • •history of urinary retention
  • •history of gastric retention
  • •uncontrolled narrow angle glaucoma
  • •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
  • •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
  • •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
  • •known hypersensitivity to solifenacin
  • •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
  • •pregnancy or trying to become pregnant
  • •breast-feeding

Arms & Interventions

PTNS and solifenacin

Active Comparator

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

Intervention: PTNS plus solifenacin (Other)

PTNS and placebo

Placebo Comparator

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

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Overactive Bladder Questionnaire, items 1-8 only

Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.

Overactive Bladder Questionnaire, items 1-8 only

Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.

Secondary Outcomes

  • 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.)
  • 3-day micturition diary(Change in Bladder diary from Baseline to 5 weeks.)
  • 3-day micturition diary(Change in Bladder diary from Baseline to 11 weeks.)
  • Urgency Perception Scale (questionnaire)(Changes in Urgency Perception from Baseline to 11 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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