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To study the role of Oxybutinin in infants affected with posterior urethral valve

Effect of early administration of oxybutynin on outcome of posterior urethral valve in infants: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056095
Enrollment
40
Registered
2023-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q642- Congenital posterior urethral valves

Interventions

Intervention1: Administration of Oxybutinin in children with diagnosed valve bladder (after posterior urethral valve fulgration) after urodynamic studies: Oxybutinin will be administered orally at a

Sponsors

Josy Thomas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants with bladder dysfunction due to posterior urethral valve who have been adequately fulgurated.

Exclusion criteria

Exclusion criteria: Infants who have not undergone adequately fulgurated or who have undergone upper urinary tract diversion procedures.

Design outcomes

Primary

MeasureTime frame
Urodynamic study will be done to record voiding pressure, bladder volume with respect to age & bladder compliance.Timepoint: Urodynamic study will be done prior to administration of oxybutynin and 3 months after administration of oxybutynin.

Secondary

MeasureTime frame
Clinical improvement Radiological improvement in bladder outline & upper renal tract UTI & efficacy/side effects of oxybutyninTimepoint: Baseline before starting oxybutynin & 3 months after starting oxybutynin.

Countries

India

Contacts

Public ContactProfessor Jai Kumar Mahajan

Post Graduate Institute of Medical Education and Research

jkmahajan@gmail.com7087008325

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026