Status:
NOT_YET_RECRUITING
Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
Lead Sponsor:
Simone Spuler, MD
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Urinary Incontinence
Epispadias, Male
Eligibility:
MALE
3-17 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.
Detailed Description
Epispadias is the mildest form of exstrophy-epispadias complex (EEC); a congenital malformation disorder involving the midline abdominal and genitourinary structures. Patients with epispadias have a d...
Eligibility Criteria
Inclusion
- Male
- Isolated epispadias
- Aged ≥ 3 years
- Urinary incontinence as defined according to the International Children´s Continence Society
- Informed consent
Exclusion
- Acute or chronic inflammatory local or systemic disease
- Coagulation Disorder
- Previous adverse reaction to anesthesia
- Congenital heart defect, cardiac arrhythmia
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04729582
Start Date
June 1 2024
End Date
October 1 2026
Last Update
August 3 2023
Active Locations (2)
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1
Clinic for Pediatric Urology in cooperation with University Hospital Regensburg, St. Hedwig Hospital
Regensburg, Germany, 93049
2
Pediatric Urology, Department for Urology University of Ulm
Ulm, Germany, 89075