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

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vesicare (solifenacin)
Vesicare (solifenacin) plus behavioral modification
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring urinary incontinence, overactive bladder, urinary frequency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lahey Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vesicare

Vesicare/behavioral modification

Arm Description

Vesicare alone

Vesicare plus behavioral modification

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.

Secondary Outcome Measures

Improvement of Symptom Severity

Full Information

First Posted
January 9, 2009
Last Updated
March 8, 2018
Sponsor
Lahey Clinic
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00821184
Brief Title
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient subject availability/findings for data analysis
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lahey Clinic
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
urinary incontinence, overactive bladder, urinary frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vesicare
Arm Type
Active Comparator
Arm Description
Vesicare alone
Arm Title
Vesicare/behavioral modification
Arm Type
Active Comparator
Arm Description
Vesicare plus behavioral modification
Intervention Type
Drug
Intervention Name(s)
Vesicare (solifenacin)
Intervention Description
5mg po qd
Intervention Type
Behavioral
Intervention Name(s)
Vesicare (solifenacin) plus behavioral modification
Other Intervention Name(s)
Vesicare (solifenacin)
Intervention Description
5 mg dose po once daily plus behavioral modification
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
Time Frame
0 week - 12 weeks
Secondary Outcome Measure Information:
Title
Improvement of Symptom Severity
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T Stoffel, M.D.
Organizational Affiliation
Lahey Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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