Trial Outcomes & Findings for Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence (NCT NCT01340066)
NCT ID: NCT01340066
Last Updated: 2013-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Change from baseline after 4 weeks of treatment.
Results posted on
2013-05-03
Participant Flow
Participants were recruited from three medical clinics during the study period of 05/06/2011 to 05/17/2012.
Participants entered a one week placebo run in period to fulfill inclusion/exclusion criteria before being randomized.
Participant milestones
| Measure |
Placebo Run-In
All subjects entered a one week placebo run in period to qualify for the study.
|
Placebo
Subjects were randomized at Visit 2
|
UISH001
Subjects were randomized at Visit 2
|
|---|---|---|---|
|
Placebo Run in Period
STARTED
|
94
|
0
|
0
|
|
Placebo Run in Period
COMPLETED
|
67
|
0
|
0
|
|
Placebo Run in Period
NOT COMPLETED
|
27
|
0
|
0
|
|
5 Week Double Blind Randomization Period
STARTED
|
0
|
33
|
34
|
|
5 Week Double Blind Randomization Period
COMPLETED
|
0
|
28
|
31
|
|
5 Week Double Blind Randomization Period
NOT COMPLETED
|
0
|
5
|
3
|
Reasons for withdrawal
| Measure |
Placebo Run-In
All subjects entered a one week placebo run in period to qualify for the study.
|
Placebo
Subjects were randomized at Visit 2
|
UISH001
Subjects were randomized at Visit 2
|
|---|---|---|---|
|
Placebo Run in Period
Screen Failures
|
27
|
0
|
0
|
|
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
|
Baseline Characteristics
Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=33 Participants
At randomization at visit 2, subjects were treated with matching placebo.
|
UISH001
n=34 Participants
At randomization at visit 2, subjects were treated with UISH001.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
All subjects
|
56.2 Year
n=5 Participants
|
52.6 Year
n=7 Participants
|
54.4 Year
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Placebo
n=33 Participants
1 drop Placebo sublingual 3 times/day
|
UISH001
n=34 Participants
1 drop UISH001 sublingual 3 times/day
|
|---|---|---|
|
Percentage of Participants With a Decrease in Leakage Events of 30% or More.
|
60.6 Percentage of participants
|
61.7 Percentage of participants
|
Adverse Events
Non-Randomized Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UISH001
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Randomized Subjects
n=27 participants at risk
Adverse Events (AEs) captured for subjects that were not randomized
|
UISH001
n=34 participants at risk
Subjects were treated with UISH001 during double blind treatment period.
|
Matching Placebo
n=33 participants at risk
Subjects were treated with matching placebo during double blind treatment period.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
2.9%
1/34 • Number of events 1 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
0.00%
0/33 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
Other adverse events
| Measure |
Non-Randomized Subjects
n=27 participants at risk
Adverse Events (AEs) captured for subjects that were not randomized
|
UISH001
n=34 participants at risk
Subjects were treated with UISH001 during double blind treatment period.
|
Matching Placebo
n=33 participants at risk
Subjects were treated with matching placebo during double blind treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
5.9%
2/34 • Number of events 2 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
3.0%
1/33 • Number of events 1 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
11.8%
4/34 • Number of events 4 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
6.1%
2/33 • Number of events 2 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
5.9%
2/34 • Number of events 3 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
0.00%
0/33 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
5.9%
2/34 • Number of events 2 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
6.1%
2/33 • Number of events 2 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/27 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
14.7%
5/34 • Number of events 5 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
6.1%
2/33 • Number of events 2 • AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
|
Additional Information
Dr. John McMichael
Beech Tree Labs, Inc.
Phone: 518-872-1144
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60