Overnight Bladder Drainage and Posterior Urethral Valve Sequelae

NCT05168358 | Unknown DMC

• 1 other identifier: OCD-PUV
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Urethral Valve

Keywords

Overnight Catheter Drainage; Posterior Urethral Valve; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of Bladder and Renal Function and Resolution of Urinary Tract Infection

  One Year

Study Arms (2)

Control group

NO INTERVENTION

This arm will include 55 patients, their parents will be taught the timed voiding regimen every 2 hours.

OCD group

EXPERIMENTAL

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

Interventions

Overnight Bladder Drainage PROCEDURE

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.

Also known as: Overnight Catheter Drainage

OCD group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, DK, Egypt

RECRUITING

Study Officials

• Ahmed Elkashef

  Urology and Nephrology Center, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Ahmed Elkashef

CONTACT

01000428981; ahmed-elkashef@hotmail.com

Ahmed Abdelhalim

CONTACT

01020245496; a_halim_2010@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahmed Elkashef

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 23, 2021
• Study Start: December 12, 2021
• Primary Completion: December 12, 2022
• Study Completion: June 12, 2023
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)