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

Beech Tree Labs

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Incontinence

Treatments: Drug: UISH001; Drug: matching placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01340066

03-2006-0081

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

UISH001

Experimental group

Treatment:

Drug: UISH001

Matching placebo

Placebo Comparator group

Treatment:

Drug: matching placebo