Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

Recruiting now · Phase 2

Conditions studied: Male Urogenital Diseases

In brief

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.

Key facts

Study ID

NCT04526353

Run by

University Hospital, Bordeaux

People needed

50

Starts

2020-09-10

Expected to finish

2028-09-10

Last updated by the study team

2026-06-10

Who can join

Age: 0 and older, up to 1. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Boys
• Aged 3 to 6 months
• Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
• Children who have had their valve resection at least 3 months before inclusion
• Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (>60cm H2O)/ small capacity bladder (<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (<10ml/cmH2O)/
• Holders of parental authority affiliated to French national health insurance
• With informed consent signed by holders of parental authority

You may not qualify if…

• Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
• Boys in whom urodynamic assessment is not possible for medical or anatomical reasons
• Boys requiring dialysis before the age of 3 months
• Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma

Where it is running

• CHU de Bordeaux — Bordeaux, France (enrolling)

Full record on ClinicalTrials.gov

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