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

NCT00773552 | Withdrawn Phase 4

• 1 other identifier: 08-0917.01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Urinary Urge; Urge Incontinence; Overactive Bladder

Keywords

OAB; overactive bladder; urinary urge; urge incontinence; urge

Outcome Measures

Primary Outcomes (1)

• 15% reduction in the amount of voids in a 24 hour period

  90 days

Secondary Outcomes (1)

• Assessing quality of life prior to treatment with respect to urge symptoms, then monitoring for improvement after treatment.

  90 days

Study Arms (2)

solifenacin succinate

EXPERIMENTAL

Group randomized into solifenacin succinate treatment

Drug: solifenacin succinate

placebo

PLACEBO COMPARATOR

Group randomized into placebo

Drug: placebo

Interventions

solifenacin succinate DRUG

5mg PO Qday x 90 days

Also known as: VESIcare

solifenacin succinate

placebo DRUG

1 tab PO Qday x 90 days

placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Stamford Hospital: lead

Study Sites (2)

Optimus Health care

Stamford, Connecticut, 06904, United States

Location

The Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (2)