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Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 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. Identifier: NCT00773552
Recruitment Status : Withdrawn (Investigator Left Institution)
First Posted : October 16, 2008
Last Update Posted : December 6, 2016
Information provided by:
Stamford Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Urinary Urge Urge Incontinence Overactive Bladder Drug: solifenacin succinate Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: solifenacin succinate
Group randomized into solifenacin succinate treatment
Drug: solifenacin succinate
5mg PO Qday x 90 days
Other Name: VESIcare

Placebo Comparator: placebo
Group randomized into placebo
Drug: placebo
1 tab PO Qday x 90 days

Primary Outcome Measures :
  1. 15% reduction in the amount of voids in a 24 hour period [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment. [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00773552

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United States, Connecticut
Optimus Health care
Stamford, Connecticut, United States, 06904
The Stamford Hospital
Stamford, Connecticut, United States, 06904
Sponsors and Collaborators
Stamford Hospital
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Responsible Party: Anthony Gaddi M.D., The Stamford Hospital Identifier: NCT00773552    
Other Study ID Numbers: 08-0917.01
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Keywords provided by Stamford Hospital:
overactive bladder
urinary urge
urge incontinence
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
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