Uroflow Measurements in Healthy Volunteers
This study has been completed.
Sponsor:
University of Rochester
Information provided by (Responsible Party):
Gunhilde Buchsbaum, University of Rochester
ClinicalTrials.gov Identifier:
NCT00714389
First received: July 8, 2008
Last updated: January 31, 2013
Last verified: January 2013
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Results First Received: January 5, 2010
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
| Condition: |
Healthy |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Urogynecology and OBGYN clinic March 2008 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| N/A |
Reporting Groups
| Description | |
|---|---|
| Spontaneous Uroflow Measurements | Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry. |
Participant Flow: Overall Study
| Spontaneous Uroflow Measurements | |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Spontaneous Uroflow Measurements | Spontaneous voids of subjects were recorded using uroflowmetry. |
Baseline Measures
| Spontaneous Uroflow Measurements | |
|---|---|
|
Number of Participants
[units: participants] |
12 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
50 ± 10 |
|
Gender
[units: participants] |
|
| Female | 12 |
| Male | 0 |
|
Region of Enrollment
[units: participants] |
|
| United States | 12 |
Outcome Measures
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Spontaneous Uroflow Measurements | Spontaneous voids of subjects were recorded using uroflowmetry. |
Other Adverse Events
| Spontaneous Uroflow Measurements | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 0/12 |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Limited number of participants |
Results Point of Contact:
Name/Title: Gunhilde Buchsbaum, MD
Organization: University of Rochester
phone: 585-273-3232
e-mail: gunhilde_buchsbaum@urmc.rochester.edu
Organization: University of Rochester
phone: 585-273-3232
e-mail: gunhilde_buchsbaum@urmc.rochester.edu
No publications provided
| Responsible Party: | Gunhilde Buchsbaum, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00714389 History of Changes |
| Other Study ID Numbers: | 22847 |
| Study First Received: | July 8, 2008 |
| Results First Received: | January 5, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |