Overnight Bladder Drainage and Posterior Urethral Valve Sequelae

Effect of Overnight Bladder Drainage on Posterior Urethral Valve Sequelae: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Posterior Urethral Valve
• Intervention / Treatment: Procedure: Overnight Bladder Drainage

Detailed Description

Posterior urethral valve (PUV) is the most common cause of bladder outlet obstruction (BOO) in boys. PUV induces damage to the smooth muscles of the bladder and ureter with subsequent damage to the renal parenchyma. All these sequelae begin antenatally and persist even after successful valve ablation.

The standard management of these sequelae includes timed voiding, double voiding, clean intermittent catheterization (CIC) to facilitate bladder emptying and anticholinergic drugs to improve poor bladder compliance. However, in some polyuric cases even voiding or catheterization as frequently as every 2 hours is not effective to maintain safe bladder volumes especially at night.

Overnight catheter drainage (OCD) of the urinary bladder has been increasingly suggested to be beneficial in protecting the upper tracts of patients with high urine output, defective and poorly compliant bladders, thus resulting in improvement of the renal function, hydronephrosis (HN) and the urodynamic changes as well.

Therefore, we hypothesize that OCD of the urinary bladder might improve bladder dynamics and subsequently lead to improvement or resolution of 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 by laboratory tests, renal and bladder ultrasonography (US), voiding cystourethrogram (VCUG) and dimercaptosuccinic acid (DMSA) scan. The bladder dynamics will also be examined by urodynamic study (UDS).

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elkashef; Phone Number: 01000428981; Email: ahmed-elkashef@hotmail.com
• Study Contact Backup: Name: Ahmed Abdelhalim; Phone Number: 01020245496; Email: a_halim_2010@yahoo.com

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt
      • Recruiting
      • Urology and nephrology center
      • Contact: Ahmed Abdelhalim; Phone Number: 01020245496; Email: a_halim_2010@yahoo.com
      • Contact: Ahmed Elkashef; Phone Number: 01000428981

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria: Patients who have;

• Persistent hydronephrosis and
• Unfavorable bladder dynamics on urodynamic study performed at least one year after posterior urethral valve ablation will be included in the study. The unfavorable bladder dynamics will be defined as poor compliance or detrusor overactivity.

Exclusion Criteria: Patients who;

• Underwent urinary diversion (e.g. vesicostomy or ureterostomy),
• Have other conditions that could affect lower urinary tract function,
• Have infravesical obstruction or
• Those who will refuse to participate in the study will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; This arm will include 55 patients, their parents will be taught the timed voiding regimen every 2 hours.
EXPERIMENTAL: OCD group; This arm will include 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.	Procedure: Overnight Bladder Drainage; Parents or caregivers of the patients will be taught to place an indwelling catheter in the bladder at bedtime for about 8-12 h under a clean technique every night for one year. The catheter will then be allowed to drain freely into a gravity drainage collecting bag or in the diapers. On the next morning, the catheter will be removed and the timed voiding regimen will be resumed.; Other Names: Overnight Catheter Drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement or Resolution of Hydronephrosis	Impact of overnight bladder drainage on improvement or resolution of hydronephrosis assessed by renal and bladder ultrasonography. Improvement of hydronephrosis will be defined as downgrading of hydronephrosis according to Society of Fetal Urology grading system.	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Bladder and Renal Function and Resolution of Urinary Tract Infection	Impact of overnight bladder drainage on bladder function evaluated by urodynamics study, renal function estimated by SCr, eGFR and DMSA scan and on febrile urinary tract infections assessed by urinalysis and urine culture.	One Year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Ahmed Abdelhalim, Urology and Nephrology Center, Mansoura University, Egypt; Study Director: Ashraf Hafez, Urology and Nephrology Center, Mansoura University, Egypt; Study Director: Mohamed Dawaba, Urology and Nephrology Center, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2021
• Primary Completion (ANTICIPATED): December 12, 2022
• Study Completion (ANTICIPATED): June 12, 2023

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: December 12, 2021
• First Posted (ACTUAL): December 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Overnight Catheter Drainage; Posterior Urethral Valve
• Other Study ID Numbers: OCD-PUV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No