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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01340066
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: UISH001 Drug: matching placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: UISH001 Drug: UISH001
sublingual dosing, 1 drop 3 times a day
Placebo Comparator: Matching placebo Drug: matching placebo
sublingual dosing,1 drop 3 times a day


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340066


Locations
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Pennsylvania
PEAK Research, LLC
Upper St. Clair, Pennsylvania, United States, 15241
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
More Information

Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT01340066     History of Changes
Other Study ID Numbers: 03-2006-0081
First Posted: April 22, 2011    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: May 3, 2013
Last Verified: March 2013

Keywords provided by Beech Tree Labs, Inc.:
urinary incontinence
stress incontinence
urge incontinence
mixed incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders