Phase 2
Completed N=94
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
Source: ClinicalTrials.gov NCT01340066 ↗Enrolled (actual)
94
Serious AEs
1.1%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants With a Decrease in Leakage Events of 30% or More. — 60.6; 61.7 Percentage of participants — p=.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.
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 |
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
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. Informational only — not medical advice.