Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Regional Clinical Research, Inc., Endwell, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UISH001

Drug

sublingual dosing, 1 drop 3 times a day

Matching Placebo

Drug

sublingual dosing,1 drop 3 times a day

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.

Sponsors and collaborators

Lead sponsor

Beech Tree Labs, Inc.

Industry

Collaborators

Norwich Clinical Research Associates Ltd.

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 22, 2011
Registry last updated: May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed