Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
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
1 other identifier
interventional
94
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
May 3, 2013
CompletedMay 3, 2013
March 1, 2013
1.1 years
April 18, 2011
February 18, 2013
March 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Decrease in Leakage Events of 30% or More.
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.
Change from baseline after 4 weeks of treatment.
Study Arms (2)
UISH001
EXPERIMENTALMatching placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women who have moderate to severe urge, stress or mixed Urinary Incontinence
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beech Tree Labs, Inc.lead
- Norwich Clinical Research Associates Ltd.collaborator
Study Sites (3)
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John McMichael
- Organization
- Beech Tree Labs, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2011
First Posted
April 22, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 3, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-03