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OpenTrials
Completed

NCT Number: NCT06787092

The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder

The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

bladder cycling

Procedure

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.

Primary outcomes

  1. measuring bladder size

    Time frame: 3 months

    measuring bladder size by ACUG

Secondary outcomes

  1. increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: PBC and DF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.