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

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stamford Hospital
• Treatments: Solifenacin Succinate

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.