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A clinical trial to study the effect Of two drugs, oxybutynin and terazocin, on bladder function, in patients of Posterior Urethral Valve after Transurethral Fulguration

Effect Of Anticholinergics And Alpha-1 Blockers On Bladder Function In Patients Of Posterior Urethral Valve After Transurethral Fulguration : A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038433
Enrollment
60
Registered
2021-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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: oxybutynin: anticholinergic agent oxybutynin at a dose of 0.2 mg/kg in two divided doses -for minimum duration of 3 months, maximum upto 6 months Control Intervention1: terazosin: alpha

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Boys aged between three months to 12 years, who have undergone primary TUF of PUV 2. Post TUF MCU showing adequate fulguration 3. Baseline UDS abnormalities including increased voiding pressure, low bladder capacity, poor compliance with elevated leak point pressure, high PVR

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone vesicostomy or upper tract diversion 2. Patients post primary TUF with post-operative MCU suggestive of incomplete fulguration 3. Patients with a normal baseline UDS 4. Patients not willing to participate in the study 5. Presence of other urethral anomalies along with PUV

Design outcomes

Primary

MeasureTime frame
1. subjective improvement in lower urinary tract symptoms 2. Bladder thickness and PVR on ultrasound 3. urodynamic changesTimepoint: 1. after 3 months 2. after 6 to 9 months

Secondary

MeasureTime frame
breakthrough UTIs changes in renal function tests Timepoint: 1. after 3 months 2. after 6 to 9 months

Countries

India

Contacts

Public ContactPalak Singhai

PGIMER chandigarh

drmuneerabas@gmail.com9796452773

Outcome results

None listed

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