Urinary Incontinence
Conditions
Keywords
urinary incontinence, stress incontinence, urge incontinence, mixed incontinence
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.
Interventions
DRUGUISH001
sublingual dosing, 1 drop 3 times a day
DRUGmatching placebo
sublingual dosing,1 drop 3 times a day
Sponsors
Norwich Clinical Research Associates Ltd.
Beech Tree Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Decrease in Leakage Events of 30% or More. | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three medical clinics during the study period of 05/06/2011 to 05/17/2012.
Pre-assignment details
Participants entered a one week placebo run in period to fulfill inclusion/exclusion criteria before being randomized.
Participants by arm
| Arm | Count |
|---|---|
| Matching Placebo At randomization at visit 2, subjects were treated with matching placebo. | 33 |
| UISH001 At randomization at visit 2, subjects were treated with UISH001. | 34 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 5 Week Double Blind Randomization Period | Adverse Event | 0 | 2 | 2 |
| 5 Week Double Blind Randomization Period | Physician Decision | 0 | 1 | 0 |
| 5 Week Double Blind Randomization Period | Withdrawal by Subject | 0 | 2 | 1 |
| Placebo Run in Period | Screen Failures | 27 | 0 | 0 |
Baseline characteristics
| Characteristic | Matching Placebo | UISH001 | Total |
|---|---|---|---|
| Age Continuous All subjects | 56.2 Year | 52.6 Year | 54.4 Year |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 15 / 34 | 7 / 33 |
| serious Total, serious adverse events | 0 / 27 | 1 / 34 | 0 / 33 |
Outcome results
Primary
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.
Time frame: Change from baseline after 4 weeks of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Decrease in Leakage Events of 30% or More. | 60.6 Percentage of participants |
| UISH001 | Percentage of Participants With a Decrease in Leakage Events of 30% or More. | 61.7 Percentage of participants |
p-value: 0.92Chi-squared