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

This study has been terminated.

( Insufficient subject availability/findings for data analysis )

First Received: January 9, 2009 Last Updated: February 17, 2009 History of Changes

Sponsors and Collaborators:	Lahey Clinic Astellas Pharma US, Inc.
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00821184

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: solifenacin Other: Solifenacin plus behavioral modification	Phase III

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Solifenacin Solifenacin succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:

The analysis of change from baseline in the number of incontinence episode per 24 hours as measured by voiding diaries (strictly counted). Testing for a difference of 35% difference. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved symptom severity measured by questionnaire. Change in number of voids per 24 hours, as measured by voiding diaries [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	September 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vesicare alone	Drug: solifenacin patients will be treated with solifenacin (Vesicare) alone
2: Active Comparator Vesicare plus behavioral modification	Other: Solifenacin plus behavioral modification solifenacin will be administered along with behavioral modification, fluid regulation, pelvic exercises, timed voiding

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821184

Locations

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

Sponsors and Collaborators

Lahey Clinic

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

John T Stoffel, M.D.

Lahey Clinic

More Information

No publications provided

Responsible Party:	John Stoffel, M.D.
Study ID Numbers:	2006-083
Study First Received:	January 9, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00821184 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

urinary incontinence
overactive bladder
urinary frequency

Study placed in the following topic categories:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists
Urination Disorders
Urinary Bladder Diseases
Cholinergic Agents

Muscarinic Antagonists
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Urination Disorders
Physiological Effects of Drugs
Urinary Bladder Diseases
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Urinary Incontinence
Urinary Incontinence, Urge

ClinicalTrials.gov processed this record on May 06, 2009