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

NCT ID: NCT00821184

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vesicare

Vesicare alone

Group Type: ACTIVE_COMPARATOR

Vesicare (solifenacin)

Intervention Type: DRUG

5mg po qd

Vesicare/behavioral modification

Vesicare plus behavioral modification

Group Type: ACTIVE_COMPARATOR

Vesicare (solifenacin) plus behavioral modification

Intervention Type: BEHAVIORAL

5 mg dose po once daily plus behavioral modification

Interventions

Vesicare (solifenacin)

5mg po qd

Intervention Type: DRUG

Vesicare (solifenacin) plus behavioral modification

5 mg dose po once daily plus behavioral modification

Intervention Type: BEHAVIORAL

Other Intervention Names

Vesicare (solifenacin)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role: collaborator

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Linda Topjian

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John T Stoffel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic

Locations

Lahey Clinic

Burlington, Massachusetts, United States

Countries

United States

Other Identifiers

2006-083

Identifier Type: -

Identifier Source: org_study_id