Spina BifidaNCT03061084
Prospective Cohort of Transitional Urology Patients
An observational study of Spina Bifida and Myelomeningocele, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spina Bifida, Myelomeningocele, Meningocele
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen in Houston Methodist transitional urology clinic with congenital genitourinary abnormalities.
Who may be able to join
- 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.
Who cannot join
- Non congenital neurogenic bladder
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Hamida Rajab, 713-363-9154, hrajab@houstonmethodist.org
Rose Khavari, MD
About this study
Official title: Long Term Assessment and Outcome of Adult Patients With Congenital Genitourinary Abnormalities.
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.
Read the 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.
- Conditions
- Spina Bifida, Myelomeningocele, Meningocele, Bladder Exstrophy, Genitourinary Congenital Anomalies, Cloacal Exstrophy
- Keywords
- Spina Bifida, Neurogenic bladder, Myelomeningocele
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele, Meningocele, Bladder Exstrophy, Urogenital Abnormalities, Cloacal Exstrophy, Urinary Bladder, Neurogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start27 Aug 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Khavari, M.D., The Methodist Hospital Research Institute
- Investigators
- Rose Khavari, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061084
- Sponsor's protocol ID
- Pro00012924
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2017
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Assessment and Outcome of Adult Patients With Congenital Genitourinary Abnormalities.
- ClinicalTrials.gov ID
- NCT03061084
- Acronym / sponsor ID
- Pro00012924
- Conditions
- Spina Bifida, Myelomeningocele, Meningocele, Bladder Exstrophy, Genitourinary Congenital Anomalies, Cloacal Exstrophy
- Keywords
- Spina Bifida, Neurogenic bladder, Myelomeningocele
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in Houston Methodist transitional urology clinic with congenital genitourinary abnormalities.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non congenital neurogenic bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life changes
Time frame: 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Spina Bifida
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Khavari, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida and Myelomeningocele, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamida Rajab (713-363-9154, hrajab@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life changes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.