NCT05168358

Overnight Bladder Drainage and Posterior Urethral Valve Sequelae

Status unknown NA Last updated 23 December 2021

What this trial tests

NA trial testing Overnight Bladder Drainage in Posterior Urethral Valve in 55 participants. Status unknown.

Timeline

12 December 2021

Primary endpoint
12 December 2022

12 June 2023

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	12 December 2021
Primary completion	12 December 2022
Estimated completion	12 June 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Overnight Bladder Drainage

Conditions studied

• Posterior Urethral Valve — all drugs for Posterior Urethral Valve →

Sponsor

Mansoura University

Who can join

Adults 1 to 18, male only, with Posterior Urethral Valve. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

We hypothesize that overnight catheter drainage (OCD) of the urinary bladder might improve bladder dynamics and subsequently lead to improvement or resolution of hydronephrosis (HN) and renal function in boys who underwent PUV ablation.

Patients who have persistent HN and bladder dysfunction at least one year after PUV ablation will be randomly allocated into two groups: the first group (control group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, while the second group (OCD group): 55 patients, their parents will be taught the timed voiding regimen every 2 hours, in addition to placing an overnight catheter to drain the urinary bladder during night.

We will study the effect of OCD of the urinary bladder on the improvement or resolution of HN and urinary bladder function within a year of starting this regimen.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.