Posterior Urethral ValveNCT05168358
Overnight Bladder Drainage and Posterior Urethral Valve Sequelae
A study testing Overnight Bladder Drainage in people with Posterior Urethral Valve, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years, men only
- Conditions the study is for
- Posterior Urethral Valve
- What is being tested?
- Overnight Bladder Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2021to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, DK
Ahmed Elkashef, 01000428981
Ahmed Abdelhalim, 01020245496, a_halim_2010@yahoo.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Posterior Urethral Valve
- Being tested
- Overnight Bladder Drainage
- Keywords
- Overnight Catheter Drainage, Posterior Urethral Valve, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight Bladder DrainageProcedure or surgery
Also called Overnight Catheter 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Overnight Bladder Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Secondary outcomes (1)
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start12 Dec 2021
- Primary completion12 Dec 2022 (estimated)
- Study completion12 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Urethral ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elkashef, Mansoura University
- Investigators
- Ahmed Elkashef, Principal investigator, Urology and Nephrology Center, Mansoura University, EgyptAhmed Abdelhalim, Study director, Urology and Nephrology Center, Mansoura University, EgyptAshraf Hafez, Study director, Urology and Nephrology Center, Mansoura University, EgyptMohamed Dawaba, Study director, Urology and Nephrology Center, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168358
- Sponsor's protocol ID
- OCD-PUV
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Overnight Bladder Drainage on Posterior Urethral Valve Sequelae: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05168358
- Acronym / sponsor ID
- OCD-PUV
- Conditions
- Posterior Urethral Valve
- Keywords
- Overnight Catheter Drainage, Posterior Urethral Valve, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 12 Dec 2022 (estimated)
- Study completion
- 12 Jun 2023 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Overnight Bladder DrainageThis 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overnight Bladder DrainageAlso: Overnight Catheter DrainageParents 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. | Procedure or surgery | OCD group |
Primary outcome
Improvement or Resolution of Hydronephrosis
Time frame: 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.
1 secondary outcome
Improvement of Bladder and Renal Function and Resolution of Urinary Tract Infection
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elkashef principal investigator
Urology and Nephrology Center, Mansoura University, Egypt
Ahmed Abdelhalim study director
Urology and Nephrology Center, Mansoura University, Egypt
Ashraf Hafez study director
Urology and Nephrology Center, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight Bladder Drainage in people with Posterior Urethral Valve, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elkashef (01000428981, ahmed-elkashef@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement or Resolution of Hydronephrosis (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.