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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Stamford Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Stamford Hospital
ClinicalTrials.gov Identifier:
NCT00773552
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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
Other Name: placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Stamford, Connecticut, United States, 06904
Principal Investigator: Anthony P Gaddi, M.D.         
Sub-Investigator: Lance Bruck, M.D.         
Sub-Investigator: Danielle Bottallico, BS         
Optimus Health care Not yet recruiting
Stamford, Connecticut, United States, 06904
Principal Investigator: Anthony p Gaddi, M.D.         
Sub-Investigator: Lance Bruck, M.D.         
Sub-Investigator: Danielle Bottallico, B.S.         
Sponsors and Collaborators
Stamford Hospital
  More Information

No publications provided

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

Keywords provided by Stamford Hospital:
OAB
overactive bladder
urinary urge
urge incontinence
urge

Additional relevant MeSH terms:
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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014