Trial Outcomes & Findings for A Feasibility Device Study to Prevent Female Urinary Stress Incontinence (NCT NCT03010800)
NCT ID: NCT03010800
Last Updated: 2018-01-18
Results Overview
Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
An hour after finishing a liter of liquid
Results posted on
2018-01-18
Participant Flow
Participant milestones
| Measure |
With Yoni.Fit First
Yoni.Fit first, then without the Yoni.Fit.
|
Without Yoni.Fit First
Without Yoni.Fit first, then with Yoni.Fit.
|
|---|---|---|
|
Initial Assignment
STARTED
|
4
|
4
|
|
Initial Assignment
COMPLETED
|
4
|
4
|
|
Initial Assignment
NOT COMPLETED
|
0
|
0
|
|
Cross Over
STARTED
|
4
|
4
|
|
Cross Over
COMPLETED
|
4
|
4
|
|
Cross Over
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
With Yoni.Fit First
n=4 Participants
With the Yoni.Fit first, then without the Yoni.Fit.
|
Without Yoni.Fit First
n=4 Participants
Without the Yoni.Fit first, then with the Yoni.Fit.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: An hour after finishing a liter of liquidComparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.
Outcome measures
| Measure |
With Yoni.Fit
n=8 Participants
Pad weights for with the Yoni.Fit
|
Without Yoni.Fit
n=8 Participants
Pad weights without Yoni.Fit.
|
|---|---|---|
|
Pad Weight Difference
Subject #1
|
0.0 grams
|
0.0 grams
|
|
Pad Weight Difference
Subject #2
|
0.0 grams
|
0.3 grams
|
|
Pad Weight Difference
Subject #3
|
0.1 grams
|
2.4 grams
|
|
Pad Weight Difference
Subject #4
|
0.3 grams
|
0.4 grams
|
|
Pad Weight Difference
Subject #5
|
0.1 grams
|
10.5 grams
|
|
Pad Weight Difference
Subject #6
|
0.1 grams
|
6.0 grams
|
|
Pad Weight Difference
Subject #7
|
0.2 grams
|
0.0 grams
|
|
Pad Weight Difference
Subject #8
|
17.3 grams
|
9.2 grams
|
Adverse Events
With Yoni.Fit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Without Yoni.Fit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Hurst
Oklahoma University Health Science Center
Phone: 405-271-3930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place