Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
- Registration Number
- NCT01340066
- Lead Sponsor
- Beech Tree Labs, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 94
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo matching placebo - UISH001 UISH001 -
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Decrease in Leakage Events of 30% or More. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
PEAK Research, LLC
🇺🇸Upper St. Clair, Pennsylvania, United States
Regional Clinical Research, Inc.🇺🇸Endwell, New York, United States