Overactive Bladder Clinical Trial
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
Verified date | December 2016 |
Source | Stamford Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Optimus Health care | Stamford | Connecticut |
United States | The Stamford Hospital | Stamford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Stamford Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 15% reduction in the amount of voids in a 24 hour period | 90 days | No | |
Secondary | Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment. | 90 days | No |
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