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Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

Expanded access is currently available for this treatment.
Verified October 2008 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765557
First Posted: October 3, 2008
Last Update Posted: October 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  Purpose

We hypothesize fecal retention is the primary source of bladder dysfunction in some children with Urge Syndrome. Our specific aims are:

  1. To test this hypothesis through a prospective, randomized, double-blinded and placebo-controlled trial of laxatives for children diagnosed with US.
  2. To determine if a validated questionnaire of bowel activity administered to the family, and when appropriate, the patient, will identify those likely to benefit from laxative therapy for bladder dysfunction.
  3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment of fecal loading corresponds to answers on the questionnaire regarding incidence of constipation, and/or response to laxative therapy for US.

Condition Intervention
Urge Syndrome Drug: Miralax

Study Type: Expanded Access     What is Expanded Access?
Official Title: Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

Further study details as provided by University of Texas Southwestern Medical Center:

Intervention Details:
    Drug: Miralax
    Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.
  Eligibility

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Toilet-trained with a history of urinary tract infection; vesicoureteral reflux; urinary incontinence; daily frequency and urgency; and diurnal incontinence.

Exclusion Criteria:

  • Children who are below 4 years old as they may still not be toilet-trained; children with encopresis; children with anorectal malformations; and children with neurologic disorders.
  Contacts and Locations
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): NCT00765557


Contacts
Contact: Warren T Snodgrass, M.D. 214-456-2483 Warren.Snodgrass@childrens.com

Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

Responsible Party: Warren T. Snodgrass, M.D., University of Texas Southwestern Medical School
ClinicalTrials.gov Identifier: NCT00765557     History of Changes
Other Study ID Numbers: 122004-038
First Submitted: September 30, 2008
First Posted: October 3, 2008
Last Update Posted: October 3, 2008
Last Verified: October 2008

Keywords provided by University of Texas Southwestern Medical Center:
To determine if laxative therapy can resolve Urge Syndrome, and if so, in which patients.
To determine usefulness of KUB, an abdominal X-ray of the kidneys, ureters, and bladder.
To predict the bowel activity of children with Urge Syndrome, who are most likely to respond to laxatives, with the use of the Bowel/Bladder questionnaire.

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Laxatives
Cathartics
Gastrointestinal Agents