Overnight Bladder Drainage and Posterior Urethral Valve Sequelae
NCT ID: NCT05168358
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
55 participants
INTERVENTIONAL
2021-12-12
2023-06-12
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
This arm will include 55 patients, their parents will be taught the timed voiding regimen every 2 hours.
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
18 Years
MALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ahmed Elkashef
Ahmed Elkashef
Principal Investigators
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Ahmed Elkashef
Role: PRINCIPAL_INVESTIGATOR
Urology and Nephrology Center, Mansoura University, Egypt
Ahmed Abdelhalim
Role: STUDY_DIRECTOR
Urology and Nephrology Center, Mansoura University, Egypt
Ashraf Hafez
Role: STUDY_DIRECTOR
Urology and Nephrology Center, Mansoura University, Egypt
Mohamed Dawaba
Role: STUDY_DIRECTOR
Urology and Nephrology Center, Mansoura University, Egypt
Locations
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Urology and Nephrology Center
Al Mansurah, DK, Egypt
Countries
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Central Contacts
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Facility Contacts
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Ahmed Elkashef
Role: primary
Ahmed Abdelhalim
Role: backup
Other Identifiers
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OCD-PUV
Identifier Type: -
Identifier Source: org_study_id