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Sponsored by: |
Stamford Hospital |
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Information provided by: | Stamford Hospital |
ClinicalTrials.gov Identifier: | NCT00773552 |
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 |
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 |
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 |
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solifenacin succinate: Experimental
Group randomized into solifenacin succinate treatment
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Drug: solifenacin succinate
5mg PO Qday x 90 days
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placebo: Placebo Comparator
Group randomized into placebo
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Drug: placebo
1 tab PO Qday x 90 days
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Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
taking any of the following contraindicated drugs:
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 |
United States, Connecticut | |
The Stamford Hospital | |
Stamford, Connecticut, United States, 06904 | |
Optimus Health care | |
Stamford, Connecticut, United States, 06904 |
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 |
OAB overactive bladder urinary urge urge incontinence urge |
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 |
Muscarinic Antagonists Urological Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Cholinergic Antagonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |