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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821184
Recruitment Status : Terminated (Insufficient subject availability/findings for data analysis)
First Posted : January 13, 2009
Results First Posted : July 30, 2010
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Linda Topjian, Lahey Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Vesicare (solifenacin) Behavioral: Vesicare (solifenacin) plus behavioral modification Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Arms and Interventions
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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 Name: Vesicare (solifenacin)


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

Secondary Outcome Measures :
  1. Improvement of Symptom Severity [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821184


Locations
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United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Astellas Pharma US, Inc.
Investigators
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Principal Investigator: John T Stoffel, M.D. Lahey Clinic
More Information
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Responsible Party: Linda Topjian, Study Coordinator, Lahey Clinic
ClinicalTrials.gov Identifier: NCT00821184    
Other Study ID Numbers: 2006-083
First Posted: January 13, 2009    Key Record Dates
Results First Posted: July 30, 2010
Last Update Posted: April 4, 2018
Last Verified: March 2018
Keywords provided by Linda Topjian, Lahey Clinic:
urinary incontinence
overactive bladder
urinary frequency
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Incontinence
Urination Disorders
 Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents