Prospective Cohort of Transitional Urology Patients

NCT03061084 | Unknown

• 1 other identifier: Pro00012924
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida; Myelomeningocele; Meningocele; Bladder Exstrophy; Genitourinary Congenital Anomalies; Cloacal Exstrophy

Keywords

Spina Bifida, Neurogenic bladder, Myelomeningocele

Outcome Measures

Primary Outcomes (1)

• Quality of life changes

  The questionnaire is generated to collect long-term data regarding patients' genitourinary status including quality of life, 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

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in Houston Methodist transitional urology clinic with congenital genitourinary abnormalities.

You may qualify if:

• \- 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.

You may not qualify if:

• \- Non congenital neurogenic bladder

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele; Meningocele; Bladder Exstrophy; Urogenital Abnormalities; Cloacal Exstrophy; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Anus, Imperforate; Digestive System Abnormalities; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rose Khavari, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamida Rajab

CONTACT

713-363-9154; hrajab@houstonmethodist.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: August 27, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)