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Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

Study acronym: PRETIPUV
StatusRecruiting
PhasePhase 2
Started2020-09-10
View on ClinicalTrials.gov ↗

Amendment history

2026-06-08
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-09-10→2028-02
Completion date2023-09-10→2028-09-10
Study sites0→1
2020-08-24
minor
Original filing
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date. Anticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable. This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.
Trial Details
NCT Number NCT04526353
Lead Sponsor University Hospital, Bordeaux
Conditions Male Urogenital Diseases
Enrollment 50 participants
Start Date 2020-09-10
Primary Completion 2028-02 (estimated)
Study Completion 2028-09-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-10