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 : March 13, 2019
|Condition or disease|
|Spina Bifida Myelomeningocele Meningocele Bladder Exstrophy Genitourinary Congenital Anomalies Cloacal Exstrophy|
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|
|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|
- 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
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
|Contact: Rashmi Pande, BDS,MS,CCRPfirstname.lastname@example.org|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Rashmi Pande, BDS,MS 713-363-9154 email@example.com|
|Principal Investigator: Rose Khavari, MD|
|Principal Investigator:||Rose Khavari, MD||The Methodist Hospital System|