Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

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.

Conditions

• Male Urogenital Diseases

Interventions

DRUG

Oxybutynin 1 mg/ml Syrup

The Investigational Medicinal Product of this study is Oxybutynin 1 mg/ml Syrup (see Annex 1 for the Monograph of PMS-Oxybutynin provided by ANSM under the ATU.). It will be administered at the dose of 0.1 mg/kg/twice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram. The recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg/kg/day, whilst the dosage we will be using is effectively 0.2mg/kg/day. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children \<1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg/kg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012

Sponsors & Collaborators

• University Hospital, Bordeaux

  lead OTHER

Principal Investigators

• Laurent L FOURCADE, MD · University Hospital, Limoges

• Alice A FAURE, MD · APHM - Hôpital Timone Enfants

• Thomas BLANC, MD · APHP - Hôpital Necker Enfants Malades

• Alaa A EL GHONEIMI, MD · APHP- Hôpital Robert Debré

• Alexis A ARNAUD, MD · Rennes University Hospital

• Ourdia O BOUALI, MD · University Hospital, Toulouse

• Jean-Baptiste JB MARRET, MD · University Hospital, Caen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

6 Months

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-10

Primary Completion

2023-09-10

Completion

2023-09-10