Phase 2 N=94 Randomized Double-blind Treatment

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

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01340066 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

May 2013

Primary outcome: Primary: Percentage of Participants With a Decrease in Leakage Events of 30% or More. — 60.6; 61.7 Percentage of participants — p=.92

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: UISH001 (Drug); matching placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Beech Tree Labs, Inc.
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Decrease in Leakage Events of 30% or More.	60.6; 61.7	.92

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01340066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.