HealthyNCT00714389
Uroflow Measurements in Healthy Volunteers
An observational study of Healthy, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urogynecology clinic
Who may be able to join
- Healthy volunteers/employees
- Normal voiding function.
- Willing to participate.
Who cannot join
- Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urogynecology and Reconstructive Pelvic Surgery Center
Rochester, New York, 14623
About this study
The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.
Read the detailed description
see above
- Conditions
- Healthy
- Keywords
- Urogynecology
What is being measured
The primary outcome is the main question the study is designed to answer.
Voided Volume
Volume of spontaneous void
Measured: March 2008
Maximal Flow Rate
Maximal uroflow of spontaneous subject voids
Measured: March 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunhilde Buchsbaum, University of Rochester
- Investigators
- Gunhilde Buchsbaum, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714389
- Sponsor's protocol ID
- 22847
- Status last verified
- Jan 2013
- First submitted
- 8 Jul 2008
- Last updated
- 6 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uroflow Measurements in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00714389
- Acronym / sponsor ID
- 22847
- Conditions
- Healthy
- Keywords
- Urogynecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 29 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.
Detailed description
see above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urogynecology clinic
Key inclusion criteria (3 listed)
- Healthy volunteers/employees
- Normal voiding function.
- Willing to participate.
Key exclusion criteria (1 listed)
- Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voided Volume
Time frame: March 2008
Volume of spontaneous void
Maximal Flow Rate
Time frame: March 2008
Maximal uroflow of spontaneous subject voids
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunhilde Buchsbaum, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voided Volume (time frame: March 2008). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.