Not Yet RecruitingPhase 1/2

Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients

Germany21 participantsStarted 2024-06

Plain-language 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.

Who can participate

Age range3 Years – 17 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male * Isolated epispadias * Aged ≥ 3 years * Urinary incontinence as defined according to the International Children´s Continence Society * Informed consent Exclusion Criteria: * Acute or chronic inflammatory local or systemic disease * Coagulation Disorder * Previous adverse reaction to anesthesia * Congenital heart defect, cardiac arrhythmia

What they're measuring

Prevalence of Intervention-related Adverse Events

Timeframe: Upto 12 months post-intervention

Change in Leak Point Pressure (LPP)

Timeframe: Six months post-intervention

Trial details

NCT IDNCT04729582

SponsorSimone Spuler, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Simone Spuler, Prof. Dr.

+49 (0) 30 450 540 501 simone.spuler@charite.de

View on ClinicalTrials.gov More Urinary Incontinence trials