Posterior Urethral Valves Clinical Trials

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Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

Who is this study for? Patients with Male Urogenital Diseases
What treatments are being studied? Oxybutynin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 3 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
Contact Information
Primary
Luke L HARPER, MD
luke.harper@chu-bordeaux.fr
05 56 79 56 17
Backup
Aurore A CAPELLI, PhD
aurore.capelli@chu-bordeaux.fr
05 57 82 08 77
Time Frame
Start Date: 2020-09-10
Estimated Completion Date: 2028-09-10
Participants
Target number of participants: 50
Treatments
Experimental: Oxybutynin during 9 months.
0.1mg / kg 2x / day from inclusion and for 9 months.
No_intervention: No oxybutynin
No treatment affecting bladder function
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov