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Determination of Voiding Patterns of Children With Vesicoureteral Reflux

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ClinicalTrials.gov Identifier: NCT00186199
Recruitment Status : Unknown
Verified June 2013 by Linda Dairiki Shortliffe, Stanford University.
Recruitment status was:  Enrolling by invitation
First Posted : September 16, 2005
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Linda Dairiki Shortliffe, Stanford University

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

Condition or disease
Vesicoureteral Reflux

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 Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Determination of Voiding Patterns of Children With Vesicoureteral Reflux
Study Start Date : June 2005
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Uroflow rate [ Time Frame: 3 months ]
    Obtain pre and postoperative uroflow after VUR correction


Secondary Outcome Measures :
  1. PVR [ Time Frame: 3 months ]
    Pre and postoperative measures



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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Linda Dairiki Shortliffe, Professor Urology, Stanford University
ClinicalTrials.gov Identifier: NCT00186199     History of Changes
Other Study ID Numbers: 1790
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Linda Dairiki Shortliffe, 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