NCT06472193 The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
| NCT ID | NCT06472193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sohag University |
| Condition | Bladder Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-02-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra. Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage. Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization. Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.
Eligibility Criteria
Inclusion Criteria: * children with neurogenic bladder dysfunction, as an alternative route for catheterization for those who are unable or unwilling to utilize the native route being sensate urethra. * in cases where bladder neck closure or reconstruction is necessary to achieve continence. * Patients with urethral valves, prune belly syndrome and bladder exstrophy, performed either as an isolated procedure enabling patients to perform clean intermittent catheterization (CIC) or in relation with concomitant bladder augmentation Exclusion Criteria: patients clinically unfit for surgery patients underwent previous traditional Mitroffanof procedure \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06472193 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Bladder Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472193 currently recruiting?
Yes, NCT06472193 is actively recruiting participants. Contact the research team at mahmoud_abdelraheem@med.sohag.edu.eg for enrollment information.
Where is the NCT06472193 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT06472193 clinical trial?
NCT06472193 is sponsored by Sohag University. The trial plans to enroll 10 participants.