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Prospective Cohort of Transitional Urology Patients

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ClinicalTrials.gov Identifier: NCT03061084
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Rose Khavari, M.D., The Methodist Hospital System

Brief Summary:
A transitional Urology database was created in parallel with National Spina Bifida registry to follow patients with complex congenital urogenital anomalies and be able to prospectively evaluate them. The investigators obtained the standardized questionnaires to collect long-term data regarding patients' genitourinary status including urine and fecal continence, sexuality, fertility, and pelvic health.

Condition or disease
Spina Bifida Myelomeningocele Meningocele Bladder Exstrophy Genitourinary Congenital Anomalies Cloacal Exstrophy

Detailed Description:

The care and management of pediatric patients with congenital genitourinary anomalies transitioning to adolescents and later adults is undergoing a period of profound transformation. Due to improvements in surgical and nonsurgical interventions, children with diverse congenital disease affecting the genitourinary tract are surviving into adulthood at far higher rates than in the past. As an example, up to 70-75% of children born with a myelomeningocele and consequent neurogenic bladder are living past the age of twenty. These new expectations, especially in the areas of sexual function, fertility and reproductive health, are creating previously unseen challenges for health care providers attempting to transition adolescents from pediatric to adult care. As this patient population continues to grow, the transitional process for urological care of congenital anomalies is progressively becoming a topic of vital importance.

We plan to advance adolescence clinical and research care and pioneering a unique and novel opportunity in transitional care.

This database will help us: 1. To develop and revise (as necessary) standards of care and treatment best practices for patients transitioning to adolescents with congenital genitourinary malformation. 2. To share evidence-based information between physicians across the country, advancing best practices for the secondary conditions of spina bifida, exstrophy, neurogenic bladder and bowel, and hydrocephalus. 3. To implement benchmarks to improve care in transitional urology clinics. 4. Evaluate the clinical cost-effectiveness of care offered.


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Assessment and Outcome of Adult Patients With Congenital Genitourinary Abnormalities.
Actual Study Start Date : August 27, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2025





Primary Outcome Measures :
  1. Quality of life changes [ Time Frame: 12 months ]
    The questionnaire is generated to collect long-term data regarding patients' genitourinary status including kidney function, urine and fecal continence, sexuality, fertility, and pelvic health. Follow up information will be collected at baseline and 12 months follow up visit



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in Houston Methodist transitional urology clinic with congenital genitourinary abnormalities.
Criteria

Inclusion Criteria:

- Primary diagnosis of congenital genitourinary abnormality leading to neurogenic bladder such as myelomeningocele, exstrophy, cerebral palsy, posterior urethral valve, congenital cardiac anomalies, chromosomal abnormalities, etc.

Exclusion Criteria:

- Any causes for neurogenic bladder that occurred after age 18.


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): NCT03061084


Contacts
Contact: Rashmi Pande, BDS,MS 713-363-9154 rpande@houstonmethodist.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Rashmi Pande, BDS,MS    713-363-9154    rpande@houstonmethodist.org   
Principal Investigator: Rose Khavari, MD         
Sponsors and Collaborators
Rose Khavari, M.D.
The Methodist Hospital System
Investigators
Principal Investigator: Rose Khavari, MD The Methodist Hospital System

Responsible Party: Rose Khavari, M.D., Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03061084     History of Changes
Other Study ID Numbers: Pro00012924
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rose Khavari, M.D., The Methodist Hospital System:
Spina Bifida,Neurogenic bladder, Myelomeningocele, Meningocele

Additional relevant MeSH terms:
Meningomyelocele
Spina Bifida Cystica
Spinal Dysraphism
Congenital Abnormalities
Bladder Exstrophy
Meningocele
Urogenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Hernia
Pathological Conditions, Anatomical