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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
UISH001
matching placebo
Sponsored by
Beech Tree Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, stress incontinence, urge incontinence, mixed incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Clinical Research, Inc.
  • Rochester Clinical Research
  • PEAK Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UISH001

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2011
Last Updated
March 22, 2013
Sponsor
Beech Tree Labs, Inc.
Collaborators
Norwich Clinical Research Associates Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01340066
Brief Title
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beech Tree Labs, Inc.
Collaborators
Norwich Clinical Research Associates Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, stress incontinence, urge incontinence, mixed incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UISH001
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
UISH001
Intervention Description
sublingual dosing, 1 drop 3 times a day
Intervention Type
Drug
Intervention Name(s)
matching placebo
Intervention Description
sublingual dosing,1 drop 3 times a day
Primary Outcome Measure Information:
Title
Percentage of Participants With a Decrease in Leakage Events of 30% or More.
Description
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.
Time Frame
Change from baseline after 4 weeks of treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PEAK Research, LLC
City
Upper St. Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States

12. IPD Sharing Statement

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

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