Trial Outcomes & Findings for Uroflow Measurements in Healthy Volunteers (NCT NCT00714389)
NCT ID: NCT00714389
Last Updated: 2013-02-06
Results Overview
Volume of spontaneous void
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
March 2008
Results posted on
2013-02-06
Participant Flow
Urogynecology and OBGYN clinic March 2008
Participant milestones
| Measure |
Spontaneous Uroflow Measurements
Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uroflow Measurements in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Spontaneous Uroflow Measurements
n=12 Participants
Spontaneous voids of subjects were recorded using uroflowmetry.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
50 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: March 2008Volume of spontaneous void
Outcome measures
| Measure |
Spontaneous Uroflow Measurements
n=12 Participants
Spontaneous voids of subjects were recorded using uroflowmetry.
|
|---|---|
|
Voided Volume
|
306 mL
Standard Deviation 148
|
PRIMARY outcome
Timeframe: March 2008Maximal uroflow of spontaneous subject voids
Outcome measures
| Measure |
Spontaneous Uroflow Measurements
n=12 Participants
Spontaneous voids of subjects were recorded using uroflowmetry.
|
|---|---|
|
Maximal Flow Rate
|
49 mL/sec
Standard Deviation 16
|
Adverse Events
Spontaneous Uroflow Measurements
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