Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder - Full Text View

Sponsored by:	Stamford Hospital
Information provided by:	Stamford Hospital
ClinicalTrials.gov Identifier:	NCT00773552

Purpose

In this study we hope to establish the prevalence of urinary urge symptoms (with or without incontinence) in a multicultural, underserved, hospital clinic population in women between the ages of 20 and 45. Quality of life (QOL) in these individuals will be examined. The goal is to show a 15% reduction in number of voids in a 24 hour period in our study population after 12 weeks of treatment with solifenacin succinate.

Hypothesis: We believe that urinary urge symptoms are under-reported in young women and believe they pose a significant strain on quality of life on otherwise young, healthy individuals. Treatment with solifenacin succinate will improve symptoms, in turn improving QOL for these individuals.

Condition	Intervention	Phase
Urinary Urge Urge Incontinence Overactive Bladder	Drug: solifenacin succinate Drug: placebo	Phase IV

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Succinic acid Solifenacin succinate Solifenacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized Double Blinded Placebo-Controlled Trial of the Once Daily 5mg Dose of Solifenacin Succinate vs. Placebo in Inner City Women Ages 20-45 With Overactive Bladder

Further study details as provided by Stamford Hospital:

Primary Outcome Measures:

15% reduction in the amount of voids in a 24 hour period [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
solifenacin succinate: Experimental Group randomized into solifenacin succinate treatment	Drug: solifenacin succinate 5mg PO Qday x 90 days
placebo: Placebo Comparator Group randomized into placebo	Drug: placebo 1 tab PO Qday x 90 days

Show Detailed Description

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Score of 8 or greater on the OAB-V8 questionnaire
Women between the ages of 20 and 45 years.
Pre-menopausal
Not Pregnant or plan on becoming during the length of the study

Exclusion Criteria:

menopause
pregnancy (including women breastfeeding, or women planning on becoming pregnant during the study); a pregnancy test will be performed prior to starting treatment.
previous diagnosis of stress urinary incontinence or mixed urinary incontinence
previous diagnosis of diabetes mellitus/diabetes insipidus
use of diuretics
neurological cause for detrusor instability
medical condition contraindicating antimuscarinic use (i.e.: narrow angle glaucoma)
urinary tract infection/cystitis/bladder stones (at time of questionnaire).
taking any of the following contraindicated drugs:
1. cisapride
2. phenothiazines: fluphenazine or fluphenazine decanoate, prochlorperazine maleate, promethazine, chlorpromazine, perphenazine, thioridazine, trifluoperazine, prochlorperazine edisylate,
3. pimozide
4. potassium salts: potassium acid phosphate, potassium citrate, potassium chloride, potassium iodide, potassium phosphate/sodium potassium.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773552

Contacts

Contact: Anthony p Gaddi, M.D.	203-276-1000 ext pgr# 325	agaddi@stamhealth.org
Contact: Lance Bruck, M.D.	203-276-7894	lbruck@stamhealth.org

Locations

United States, Connecticut
The Stamford Hospital
Stamford, Connecticut, United States, 06904
Optimus Health care
Stamford, Connecticut, United States, 06904

Sponsors and Collaborators

Stamford Hospital

More Information

Responsible Party:	The Stamford Hospital ( Anthony Gaddi M.D. )
Study ID Numbers:	08-0917.01
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773552
Health Authority:	United States: Institutional Review Board

Keywords provided by Stamford Hospital:

OAB
overactive bladder
urinary urge
urge incontinence
urge

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urination Disorders

Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009