UrogynecologyNCT00919048
Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers
An observational study of Urogynecology, run by University of Rochester at 1 site in United States.
Trial summary
To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urogynecology
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Urogynecology clinic
Who may be able to join
- All patients who underwent urodynamics at the urogynecology clinic during the past 12 months
- Voids larger than 50 mls.
Who cannot join
- History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.
Trial locations and contacts
1 site in 1 country.
About this study
To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.
- Conditions
- Urogynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urodynamic patients | Uroflow studies of patients who underwent urodynamics as part of an incontinence work-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding variables of patients will be compared to those of healthy female volunteers collected from another study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrogynecologyStudies 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
- Retrospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Gunhilde Buchsbaum, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919048
- Sponsor's protocol ID
- 25597
- Status last verified
- Dec 2009
- First submitted
- 10 Jun 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00919048
- Acronym / sponsor ID
- 25597
- Conditions
- Urogynecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urodynamic patients | – | –Uroflow studies of patients who underwent urodynamics as part of an incontinence work-up. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Urogynecology clinic
Key inclusion criteria (2 listed)
- All patients who underwent urodynamics at the urogynecology clinic during the past 12 months
- Voids larger than 50 mls.
Key exclusion criteria (1 listed)
- History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.
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
Voiding variables of patients will be compared to those of healthy female volunteers collected from another study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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Not yet recruitingObservational study
Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients
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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 Urogynecology, 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 2 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 16 Dec 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Voiding variables of patients will be compared to those of healthy female volunteers collected from another study.. 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 16 Dec 2009.