Bladder Cycling, Defunctionalized BladderPBC and DFNCT06787092
The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder
A study testing bladder cycling in people with Bladder Cycling, Defunctionalized Bladder, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cycling, Defunctionalized Bladder
- What is being tested?
- bladder cycling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2022to 1 Dec 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 16 years and older.
- ESRD patients maintained on hemodialysis for more than 12 months.
- Have oliguria or anuria
- reduced bladder capacity (less than 100 ml) assessed by cystogram.
Who cannot join
- 1- Previous bladder or pelvic surgery or procedure having affected the bladder function.
- 2- Neurogenic bladder dysfunction. 3-Patients with history of lower urinary tract symptoms before developing renal failure.
- 4-Those with lower urinary tract disease resulting in renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder
Read the detailed description
Kidney transplantation still remains the best treatment for end-stage renal disease (ESRD). Indeed, increasing numbers of patients are referred for transplantation, but there has been no concomitant increase in the supply of kidneys from the traditional donor pool. Many potential recipients awaiting transplantation, therefore must undergo dialysis for a long time. Regarding the detrimental effect of long-term dialysis associated with oliguria or anuria on the lower urinary tract, and especially in bladder, the interruption of physiological cycle of storage and voiding brings to a situation called Defunctionalized Bladder (DB) in which the bladder capacity became smaller in size. (Errando et al 2018).
In this study we will evaluate the outcome of renal transplantation into a defunctionalized bladder by comparing direct transplantation into this defunctionalized bladder and pre-transplant programmed bladder cycling.
- Being tested
- bladder cycling
- Keywords
- bladder cycling, defunctionalized bladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder cyclingProcedure or surgery
started by the instillation of the sterile water in the bladder in amount equal to the estimated bladder capacity. Then the amount will be gradually increased till the patient can withstand filling the bladder with 250 cc of sterile saline for 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Egyptian patients attending Ain Shams University hospitals | Experimental | ESRD patients maintained on hemodialysis for more than 12 months having oliguria or anuria with reduced bladder capacity (less than 100 ml) assessed by cystogram. Receives: Procedure: bladder cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring bladder size
measuring bladder size by ACUG
Measured: 3 months
Secondary outcomes (1)
increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start21 Mar 2022
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder Cycling, Defunctionalized BladderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- the study main objective is to describe various parameters related to bladder functionality in renal transplanted cases with defunctionalized bladder when treated with pre-transplant bladder cycling and due to limited data available, estimation of sample size will be based on effect size. A sample size of at least 20 cases achieves a power of 80% to detect a large effect size of 0.7 comparing pre- and post- cystometric capacity using paired t-test with level of significance of 0.05.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shaker, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787092
- Sponsor's protocol ID
- bladder cycling
- Acronym
- PBC and DF
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all my IPD can be shared
Publications
Silverii H, Cain MP. A novel approach to bladder cycling for defunctionalized bladders prior to pediatric kidney transplantation: A case series. J Pediatr Urol. 2024 Aug;20(4):762-764. doi: 10.1016/j.jpurol.2024.03.022. Epub 2024 Mar 24.
PubMed 38570243Osman Y, Zahran MH, Harraz AM, Mashaly M, Kamal AI, Ali-El-Dein B. Utility of Pre-Transplant Bladder Cycling for Patients With a Defunctionalized Bladder. A Randomized Controlled Trial. Urology. 2023 Apr;174:172-178. doi: 10.1016/j.urology.2023.01.008. Epub 2023 Jan 19.
PubMed 36682701
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder
- ClinicalTrials.gov ID
- NCT06787092
- Acronym / sponsor ID
- PBC and DF / bladder cycling
- Keywords
- bladder cycling, defunctionalized bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Jan 2025 (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.
The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder
Detailed description
Kidney transplantation still remains the best treatment for end-stage renal disease (ESRD). Indeed, increasing numbers of patients are referred for transplantation, but there has been no concomitant increase in the supply of kidneys from the traditional donor pool. Many potential recipients awaiting transplantation, therefore must undergo dialysis for a long time. Regarding the detrimental effect of long-term dialysis associated with oliguria or anuria on the lower urinary tract, and especially in bladder, the interruption of physiological cycle of storage and voiding brings to a situation called Defunctionalized Bladder (DB) in which the bladder capacity became smaller in size. (Errando et al 2018).
In this study we will evaluate the outcome of renal transplantation into a defunctionalized bladder by comparing direct transplantation into this defunctionalized bladder and pre-transplant programmed bladder cycling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the study main objective is to describe various parameters related to bladder functionality in renal transplanted cases with defunctionalized bladder when treated with pre-transplant bladder cycling and due to limited data available, estimation of sample size will be based on effect size. A sample size of at least 20 cases achieves a power of 80% to detect a large effect size of 0.7 comparing pre- and post- cystometric capacity using paired t-test with level of significance of 0.05.
| Arm | Type | Receives |
|---|---|---|
| Egyptian patients attending Ain Shams University hospitals | Experimental | Procedure: bladder cyclingESRD patients maintained on hemodialysis for more than 12 months having oliguria or anuria with reduced bladder capacity (less than 100 ml) assessed by cystogram. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16 years and older.
- ESRD patients maintained on hemodialysis for more than 12 months.
- Have oliguria or anuria
- reduced bladder capacity (less than 100 ml) assessed by cystogram.
Key exclusion criteria (3 listed)
- 1- Previous bladder or pelvic surgery or procedure having affected the bladder function.
- 2- Neurogenic bladder dysfunction. 3-Patients with history of lower urinary tract symptoms before developing renal failure.
- 4-Those with lower urinary tract disease resulting in renal failure.
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 |
|---|---|---|
| bladder cyclingstarted by the instillation of the sterile water in the bladder in amount equal to the estimated bladder capacity. Then the amount will be gradually increased till the patient can withstand filling the bladder with 250 cc of sterile saline for 2 hours. | Procedure or surgery | Egyptian patients attending Ain Shams University hospitals |
Primary outcome
measuring bladder size
Time frame: 3 months
measuring bladder size by ACUG
1 secondary outcome
increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Results publication: PubMed 38570243Silverii H, Cain MP. A novel approach to bladder cycling for defunctionalized bladders prior to pediatric kidney transplantation: A case series. J Pediatr Urol. 2024 Aug;20(4):762-764. doi: 10.1016/j.jpurol.2024.03.022. Epub 2024 Mar 24.
- Results publication: PubMed 36682701Osman Y, Zahran MH, Harraz AM, Mashaly M, Kamal AI, Ali-El-Dein B. Utility of Pre-Transplant Bladder Cycling for Patients With a Defunctionalized Bladder. A Randomized Controlled Trial. Urology. 2023 Apr;174:172-178. doi: 10.1016/j.urology.2023.01.008. Epub 2023 Jan 19.
- Individual participant dataSharing planned: Yes. all my IPD can be shared
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bladder cycling in people with Bladder Cycling, Defunctionalized Bladder, run by Ain Shams 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring bladder size (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787092, which also lists 2 linked publications.
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 22 Jan 2025.