A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of UISH001 for the Symptomatic Improvement of Urinary Incontinence

Beech Tree Labs, Inc.3 sites in 1 country94 target enrollmentApril 2011

ConditionsUrinary Incontinence

InterventionsUISH001 matching placebo

DrugsUISH001 matching placebo

Overview

Phase: Phase 1
Intervention: UISH001
Conditions: Urinary Incontinence
Sponsor: Beech Tree Labs, Inc.
Enrollment: 94
Locations: 3
Primary Endpoint: Percentage of Participants With a Decrease in Leakage Events of 30% or More.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

May 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Beech Tree Labs, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women who have moderate to severe urge, stress or mixed Urinary Incontinence

Exclusion Criteria

•Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression.
•Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD)
•Certain restricted medications
•Any other condition that would interfere with the safety of the subject

Arms & Interventions

UISH001

Intervention: UISH001

Matching placebo

Intervention: matching placebo

Outcomes

Primary Outcomes

Percentage of Participants With a Decrease in Leakage Events of 30% or More.

Time Frame: Change from baseline after 4 weeks of treatment.

Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.