Overnight Bladder Drainage and Posterior Urethral Valve Sequelae

Not Applicable

• Conditions: Posterior Urethral Valve
• Interventions: Procedure: Overnight Bladder Drainage

• Registration Number: NCT05168358
• Lead Sponsor: Mansoura University

Brief Summary

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-12
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2021-12-12
• Last Update Submitted: 2021-12-12
• Study First Posted: 2021-12-23
• Last Update Posted: 2021-12-23
• Primary Completion: 2022-12-12
• Study Completion: 2023-06-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 55

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCD group	Overnight Bladder Drainage	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.

Primary Outcome Measures

Name	Time	Method
Improvement or Resolution of Hydronephrosis	One Year	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.

Secondary Outcome Measures

Name	Time	Method
Improvement of Bladder and Renal Function and Resolution of Urinary Tract Infection	One Year	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.

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, DK, Egypt