Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Urinary Urge, Urge Incontinence, Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT00773552
- Run by
- Stamford Hospital
- People needed
- 0
- Starts
- 2008-11-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2016-12-06
Who can join
Age: 20 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Optimus Health care — Stamford, Connecticut, United States
- The Stamford Hospital — Stamford, Connecticut, United States
Full record on ClinicalTrials.gov
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