Recruiting

Observational Study

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT03061084

Conditions

Spina Bifida

Myelomeningocele

Meningocele

Bladder Exstrophy

Genitourinary Congenital Anomalies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03061084

Start date

Aug 27, 2015

Status verified date

Feb, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

- Non congenital neurogenic bladder

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Quality of life changes [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Hamida Rajab

713-363-9154hrajab@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Hamida Rajab

713-363-9154hrajab@houstonmethodist.org

Principal Investigator:

Rose Khavari, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Feb 6, 2023

Last verified

Feb, 2023

Keywords

  • Spina Bifida, Neurogenic bladder, Myelomeningocele

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2023-02-06.