Trial Outcomes & Findings for Feasibility Study Evaluating the ParaPatch System (NCT NCT02278146)
NCT ID: NCT02278146
Last Updated: 2017-01-24
Results Overview
Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
up to 3 weeks
Results posted on
2017-01-24
Participant Flow
Participant milestones
| Measure |
1) Stress Urinary Incontinence
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
2) Overactive Bladder
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study Evaluating the ParaPatch System
Baseline characteristics by cohort
| Measure |
1) Stress Urinary Incontinence
n=6 Participants
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
2) Overactive Bladder
n=10 Participants
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Female
|
6 participants
n=93 Participants
|
10 participants
n=4 Participants
|
16 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 3 weeksDocumentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.
Outcome measures
| Measure |
1) Stress Urinary Incontinence
n=8 Participants
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
2) Overactive Bladder
n=6 Participants
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
|---|---|---|
|
Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
|
8 participants
|
6 participants
|
SECONDARY outcome
Timeframe: up to 3 weeksPercentage of participants with less daily leaks from baseline to 3 weeks.
Outcome measures
| Measure |
1) Stress Urinary Incontinence
n=6 Participants
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
2) Overactive Bladder
n=8 Participants
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
|---|---|---|
|
Stress Incontinence Arm
|
83 percentage of subjects
|
75 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 3 weeksPercentage of participants with less daily voids from baseline to 3 weeks.
Outcome measures
| Measure |
1) Stress Urinary Incontinence
n=6 Participants
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
2) Overactive Bladder
n=8 Participants
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
ParaPatch: A device for the treatment of urinary incontinence
|
|---|---|---|
|
Overactive Bladder Arm
|
83 percentage of participants
|
75 percentage of participants
|
Adverse Events
1) Stress Urinary Incontinence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2) Overactive Bladder
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place