Clinical trial NCT06787092: The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder
Official title: The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cycling, Defunctionalized Bladder
Keywords: bladder cycling, defunctionalized bladder
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 16 years and older.
2. ESRD patients maintained on hemodialysis for more than 12 months.
3. Have oliguria or anuria
4. reduced bladder capacity (less than 100 ml) assessed by cystogram.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: measuring bladder size
timeFrame: 3 months
Secondary outcomes:
measure: increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
References:
citation: 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.
citation: Osman 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.