Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder

March 8, 2018 updated by: Linda Topjian, Lahey Clinic

A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

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
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients > 18 years of age
  • OAB symptoms for > 3 months
  • Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
  • May or may not be accompanied by urinary frequency
  • May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria:

  • Male Patients
  • Underlying cortical or spinal cord pathology including SCI, MS, or
  • Parkinson's Disease
  • Urinary retention with post-void residual > 150cc
  • Current treatment or treatment within the last 3 months with anticholinergic medications
  • Patients not able to complete the questionaires or voiding diaries in English
  • Pregnancy
  • Active urinary tract infections
  • Bladder Cancer or unevaluated hematuria
  • Known diagnosis of narrow angle glaucoma
  • Severe constipation
  • History of reduced renal function (CrCl<30ml/min)
  • History of liver disease
  • Current treatment with cytochrome P450 inhibitor medications

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vesicare
Vesicare alone
Drug: Vesicare (solifenacin)
5mg po qd
Active Comparator: Vesicare/behavioral modification
Vesicare plus behavioral modification
Behavioral: Vesicare (solifenacin) plus behavioral modification
5 mg dose po once daily plus behavioral modification
Other Names:
  • Vesicare (solifenacin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Time Frame: 0 week - 12 weeks
0 week - 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of Symptom Severity
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Lahey Clinic

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: John T Stoffel, M.D., Lahey Clinic

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

September 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-083

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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