Bladder ExstrophyNCT04580186
Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience
An observational study of Bladder Exstrophy, run by Assiut University.
Trial summary
1. To review surgical and medical outcomes of the previous repaired bladder exstrophy cases. 2. To present recent developments in surgical techniques and care of these patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bladder Exstrophy
- What is being tested?
- bladder exstrophy repair
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2021to 30 Dec 2022
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: : patients with bladder exstrophy attending assiut university urology hospital
Who may be able to join
- All patient with CBE who underwent repair at Assiut university hospital.
Who cannot join
- Cloacal exstrophy isolated epispadias previous failed repair out Assiut university hospital
Trial locations and contacts
No sites are listed yet.
About this study
- To review surgical and medical outcomes of the previous repaired bladder exstrophy cases.
- To present recent developments in surgical techniques and care of these patients.
Read the detailed description
- Exstrophy-epispadias complex (EEC) is a spectrum of genitourinary malformations resulting from abnormal cloacal development .
- CBE, the most common form with an incidence of 2.68 in 100,000 live births is characterized by an evaginated bladder plate, epispadias and an anterior defect of the pelvis, pelvic floor and abdominal wall
- The single most important predictor of long-term bladder growth and continence is successful primary bladder closure .
- The staged reconstruction of bladder exstrophy was proposed by Jeff and led to significant improvements in continence and renal function with excellent cosmetic results.
- The initial staged management consisted of newborn bladder and posterior urethral closure followed by bladder neck reconstruction at 2 to 3 years of age and later epispadias repair.
- The understanding that appropriately timed epispadias repair may lead to enhancement in bladder capacity led to performance of epispadias repair at 2 to 3 years of age followed by later bladder neck reconstruction. The current modification of the staged repair consists of secure bladder and posterior urethral closure in infancy followed by epispadias repair at 6 to 12 months of age and bladder neck reconstruction when the patient is able to cooperate in a good voiding program.
- Complete repair surgery is performed in a single procedure that closes the bladder and the abdomen and repairs the urethra and outer sex organs
- A failed classic bladder exstrophy (CBE) closure is defined by wound dehiscence, bladder prolapse, bladder outlet obstruction, or formation of a vesicocutaneous fistula.
- Conditions
- Bladder Exstrophy
- Being tested
- bladder exstrophy repair
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder exstrophy repairProcedure or surgery
primary complete bladder exstrophy repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate results of the technique used for bladder exstrophy repair
complete bladder exstrophy repair
Measured: base line
Secondary outcomes (1)
Present recent development in care and repair of these patients
update in surgical technique
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 May 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bladder ExstrophyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Emad Eldin Anwar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580186
- Sponsor's protocol ID
- bladder extrophy
- Status last verified
- Apr 2021
- First submitted
- 2 Oct 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jayachandran D, Bythell M, Platt MW, Rankin J. Register based study of bladder exstrophy-epispadias complex: prevalence, associated anomalies, prenatal diagnosis and survival. J Urol. 2011 Nov;186(5):2056-60. doi: 10.1016/j.juro.2011.07.022. Epub 2011 Sep 25.
PubMed 21944104Mayo C, Hendricks W. Exstrophy of the bladder. Surg Gynecol Obstet. 1926;43:129-34.
Jeffs RD. Functional closure of bladder exstrophy. Birth Defects Orig Artic Ser. 1977;13(5):171-3. No abstract available.
PubMed 588684Chan DY, Jeffs RD, Gearhart JP. Determinants of continence in the bladder exstrophy population: predictors of success? Urology. 2001 Apr;57(4):774-7. doi: 10.1016/s0090-4295(00)01102-x.
PubMed 11306402Novak TE, Costello JP, Orosco R, Sponseller PD, Mack E, Gearhart JP. Failed exstrophy closure: management and outcome. J Pediatr Urol. 2010 Aug;6(4):381-4. doi: 10.1016/j.jpurol.2009.10.009. Epub 2009 Nov 10.
PubMed 19906564
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience
- ClinicalTrials.gov ID
- NCT04580186
- Acronym / sponsor ID
- bladder extrophy
- Conditions
- Bladder Exstrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Oct 2020 (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.
- To review surgical and medical outcomes of the previous repaired bladder exstrophy cases.
- To present recent developments in surgical techniques and care of these patients.
Detailed description
- Exstrophy-epispadias complex (EEC) is a spectrum of genitourinary malformations resulting from abnormal cloacal development .
- CBE, the most common form with an incidence of 2.68 in 100,000 live births is characterized by an evaginated bladder plate, epispadias and an anterior defect of the pelvis, pelvic floor and abdominal wall
- The single most important predictor of long-term bladder growth and continence is successful primary bladder closure .
- The staged reconstruction of bladder exstrophy was proposed by Jeff and led to significant improvements in continence and renal function with excellent cosmetic results.
- The initial staged management consisted of newborn bladder and posterior urethral closure followed by bladder neck reconstruction at 2 to 3 years of age and later epispadias repair.
- The understanding that appropriately timed epispadias repair may lead to enhancement in bladder capacity led to performance of epispadias repair at 2 to 3 years of age followed by later bladder neck reconstruction. The current modification of the staged repair consists of secure bladder and posterior urethral closure in infancy followed by epispadias repair at 6 to 12 months of age and bladder neck reconstruction when the patient is able to cooperate in a good voiding program.
- Complete repair surgery is performed in a single procedure that closes the bladder and the abdomen and repairs the urethra and outer sex organs
- A failed classic bladder exstrophy (CBE) closure is defined by wound dehiscence, bladder prolapse, bladder outlet obstruction, or formation of a vesicocutaneous fistula.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- : patients with bladder exstrophy attending assiut university urology hospital
Key inclusion criteria (1 listed)
- All patient with CBE who underwent repair at Assiut university hospital.
Key exclusion criteria (1 listed)
- Cloacal exstrophy isolated epispadias previous failed repair out Assiut university hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bladder exstrophy repairprimary complete bladder exstrophy repair | Procedure or surgery | – |
Primary outcome
Evaluate results of the technique used for bladder exstrophy repair
Time frame: base line
complete bladder exstrophy repair
1 secondary outcome
Present recent development in care and repair of these patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 21944104Jayachandran D, Bythell M, Platt MW, Rankin J. Register based study of bladder exstrophy-epispadias complex: prevalence, associated anomalies, prenatal diagnosis and survival. J Urol. 2011 Nov;186(5):2056-60. doi: 10.1016/j.juro.2011.07.022. Epub 2011 Sep 25.
- BackgroundMayo C, Hendricks W. Exstrophy of the bladder. Surg Gynecol Obstet. 1926;43:129-34.
- Background: PubMed 588684Jeffs RD. Functional closure of bladder exstrophy. Birth Defects Orig Artic Ser. 1977;13(5):171-3. No abstract available.
- Background: PubMed 11306402Chan DY, Jeffs RD, Gearhart JP. Determinants of continence in the bladder exstrophy population: predictors of success? Urology. 2001 Apr;57(4):774-7. doi: 10.1016/s0090-4295(00)01102-x.
- Background: PubMed 19906564Novak TE, Costello JP, Orosco R, Sponseller PD, Mack E, Gearhart JP. Failed exstrophy closure: management and outcome. J Pediatr Urol. 2010 Aug;6(4):381-4. doi: 10.1016/j.jpurol.2009.10.009. Epub 2009 Nov 10.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Exstrophy, run by Assiut University.
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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 mohamed emad eldin, master (01010685968, mohamed.emad@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate results of the technique used for bladder exstrophy repair (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580186, which also lists 5 linked publications.
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 27 Apr 2021.