Status:
WITHDRAWN
Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder
Lead Sponsor:
Stamford Hospital
Conditions:
Urinary Urge
Urge Incontinence
Eligibility:
FEMALE
20-45 years
Phase:
PHASE4
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 an...
Detailed Description
* Study type: 1) Prospective, questionnaire based study 2) Randomized, double blinded, placebo-controlled trial * Setting: OB-GYN, general medicine, and family medicine clinics at the Stamford Optimus...
Eligibility Criteria
Inclusion
- 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
- 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:
- cisapride
- phenothiazines: fluphenazine or fluphenazine decanoate, prochlorperazine maleate, promethazine, chlorpromazine, perphenazine, thioridazine, trifluoperazine, prochlorperazine edisylate,
- pimozide
- potassium salts: potassium acid phosphate, potassium citrate, potassium chloride, potassium iodide, potassium phosphate/sodium potassium.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00773552
Start Date
November 1 2008
End Date
April 1 2009
Last Update
December 6 2016
Active Locations (2)
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1
Optimus Health care
Stamford, Connecticut, United States, 06904
2
The Stamford Hospital
Stamford, Connecticut, United States, 06904