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

May 22, 2014 updated by: Bay State Clinical Trials, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Bay State Clinical Trials, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overactive Bladder Questionnaire, items 1-8 only
Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
Overactive Bladder Questionnaire, items 1-8 only
Time Frame: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-day micturition diary
Time Frame: 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)
Change in Bladder diary from Baseline to 5 weeks.
3-day micturition diary
Time Frame: 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)
Change in Bladder diary from Baseline to 11 weeks.
3-day micturition diary
Time Frame: 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)
Change in Bladder diary from Baseline to 15 weeks.
Urgency Perception Scale (questionnaire)
Time Frame: Changes in Urgency Perception from Baseline to 11 weeks.
Changes in Urgency Perception from Baseline to 11 weeks.
Urgency Perception Scale (questionnaire)
Time Frame: Changes in Urgency Perception from Baseline to 15 weeks.
Changes in Urgency Perception from Baseline to 15 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bay State Clinical Trials, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSU-SOL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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