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

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

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 2008

Volume of spontaneous void

Outcome measures

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 2008

Maximal uroflow of spontaneous subject voids

Outcome measures

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

Gunhilde Buchsbaum, MD

University of Rochester

Phone: 585-273-3232

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place