Determination of Voiding Patterns of Children With Vesicoureteral Reflux

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Linda Dairiki Shortliffe, Stanford University
ClinicalTrials.gov Identifier:
NCT00186199
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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


Condition
Vesicoureteral Reflux

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Determination of Voiding Patterns of Children With Vesicoureteral Reflux

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Uroflow rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Obtain pre and postoperative uroflow after VUR correction


Secondary Outcome Measures:
  • PVR [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pre and postoperative measures


Estimated Enrollment: 250
Study Start Date: June 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any voiding disorder, musculoskeletal neurologic disorders, other congenital or acquired genitourinary problems, growth disorders, recent UTI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186199

Locations
United States, California
Lucile Packard Childrens Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Linda Shortliffe, MD Department of Urology, Stanford University
  More Information

No publications provided

Responsible Party: Linda Dairiki Shortliffe, Professor Urology, Stanford University
ClinicalTrials.gov Identifier: NCT00186199     History of Changes
Other Study ID Numbers: 1790
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
voiding patterns
flow rate
ultrasound

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 16, 2014