Vesicoureteral RefluxNCT00186199
Determination of Voiding Patterns of Children With Vesicoureteral Reflux
An observational study of Vesicoureteral Reflux, run by Stanford University at 1 site in United States.
Trial summary
Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Vesicoureteral Reflux
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Feb 2012
- How long will I take part?
- 12 Months
- 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with history of vesicoureteral reflux, toilet trained, ambulatory, and able to void on command. Children scheduled to have procedural correction of vesicoureteral reflux
Who may be able to join
- Children with or without vesicoureteral reflux (history of VUR)
- Toilet trained and can void on command
Who cannot join
- Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Childrens Hospital
Stanford, California, 94305
About this study
Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR.
Read the detailed description
We hope to determine the statistical difference between the flow rate and volume of urination in children with VUR compared to those without.
- Conditions
- Vesicoureteral Reflux
- Keywords
- voiding patterns, flow rate, ultrasound
- Medical subject headings
- Vesico-Ureteral Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Uroflow rate
Obtain pre and postoperative uroflow after VUR correction
Measured: 3 months
Secondary outcomes (1)
PVR
Pre and postoperative measures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Dairiki Shortliffe, Stanford University
- Investigators
- Linda Shortliffe, MD, Principal investigator, Department of Urology, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186199
- Sponsor's protocol ID
- 1790
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2005
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Voiding Patterns of Children With Vesicoureteral Reflux
- ClinicalTrials.gov ID
- NCT00186199
- Acronym / sponsor ID
- 1790
- Conditions
- Vesicoureteral Reflux
- Keywords
- voiding patterns, flow rate, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2005 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Sep 2005 (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.
Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR.
Detailed description
We hope to determine the statistical difference between the flow rate and volume of urination in children with VUR compared to those without.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with history of vesicoureteral reflux, toilet trained, ambulatory, and able to void on command. Children scheduled to have procedural correction of vesicoureteral reflux
Key inclusion criteria (2 listed)
- Children with or without vesicoureteral reflux (history of VUR)
- Toilet trained and can void on command
Key exclusion criteria (1 listed)
- Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI
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
Uroflow rate
Time frame: 3 months
Obtain pre and postoperative uroflow after VUR correction
1 secondary outcome
PVR
Time frame: 3 months
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 14 Sep 2022.
Related trials for Vesicoureteral Reflux
Not yet recruitingPhase 1
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Vesico-Ureteral Reflux
RecruitingObservational study
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups
Vesicoureteral Reflux 3
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Not yet recruiting
Diagnostic Performance of PIC Cystogram vs VCUG in Children
Pediatric Urology
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux
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.
Linda Shortliffe, MD principal investigator
Department of Urology, Stanford University
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 Vesicoureteral Reflux, run by Stanford University 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 14 Sep 2022. 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?
Uroflow rate (time frame: 3 months). 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 14 Sep 2022.