NCT00186199

Brief Summary

Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR) compared to those who do not have VUR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

6.7 years

First QC Date

September 13, 2005

Last Update Submit

September 12, 2022

Conditions

Vesicoureteral Reflux

Keywords

voiding patternsflow rateultrasound

Outcome Measures

Primary Outcomes (1)

  • Uroflow rate

    Obtain pre and postoperative uroflow after VUR correction

    3 months

Secondary Outcomes (1)

  • PVR

    3 months

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Children with or without vesicoureteral reflux (history of VUR)
  • Toilet trained and can void on command

You may not qualify if:

  • Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Linda Shortliffe, MD

    Department of Urology, Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Urology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2005

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

US(1)