A Phase 1/2 interventional study of UISH001 and matching placebo in Urinary Incontinence, sponsored by Beech Tree Labs, Inc.. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Beech Tree Labs, Inc. · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 94 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Beech Tree Labs, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: UISH001
Drug: matching placebo
sublingual dosing, 1 drop 3 times a day
sublingual dosing,1 drop 3 times a day
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.
Participants were recruited from three medical clinics during the study period of 05/06/2011 to 05/17/2012.
| Milestone | Placebo Run-In | Placebo | UISH001 |
|---|---|---|---|
| Started | 94 | 0 | 0 |
| Completed | 67 | 0 | 0 |
| Not completed | 27 | 0 | 0 |
| Withdrew: Screen failures | 27 | 0 | 0 |
| Milestone | Placebo Run-In | Placebo | UISH001 |
|---|---|---|---|
| Started | 0 | 33 | 34 |
| Completed | 0 | 28 | 31 |
| Not completed | 0 | 5 | 3 |
| Withdrew: Adverse event | 0 | 2 | 2 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 1 |
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.
| Percentage of participants | Placebo | UISH001 |
|---|---|---|
| Percentage of Participants With a Decrease in Leakage Events of 30% or More. | 60.6 | 61.7 |
Collected over AEs were collected from the time of informed consent to the end of the study (6 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-Randomized Subjects | — | 0/27 (0%) | 0/27 (0%) |
| UISH001 | — | 1/34 (2.9%) | 15/34 (44.1%) |
| Matching Placebo | — | 0/33 (0%) | 7/33 (21.2%) |
| Event | Non-Randomized Subjects | UISH001 | Matching Placebo |
|---|---|---|---|
| Atrial FibrillationCardiac disorders | 0/27 | 1/34 | 0/33 |
| Event | Non-Randomized Subjects | UISH001 | Matching Placebo |
|---|---|---|---|
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 0/27 | 5/34 | 2/33 |
| DiarrheaGastrointestinal disorders | 0/27 | 4/34 | 2/33 |
| HeadacheNervous system disorders | 0/27 | 2/34 | 2/33 |
| VomitingGastrointestinal disorders | 0/27 | 2/34 | 1/33 |
| NauseaGastrointestinal disorders | 0/27 | 2/34 | 0/33 |
Baseline characteristics only for subjects that were randomized into the study.
| Age Continuous(Year) | Matching Placebo | UISH001 | Total |
|---|---|---|---|
| All subjects | 56.2 (36 to 92) | 52.6 (22 to 88) | 54.4 (22 to 92) |
| Sex: Female, Male(Participants) | Matching Placebo | UISH001 | Total |
|---|---|---|---|
| Female | 33 | 34 | 67 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Beech Tree Labs, Inc.