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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bladder Cycling, Defunctionalized Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Egyptian patients attending Ain Shams University hospitals

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.

Group Type EXPERIMENTAL

bladder cycling

Intervention Type 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.

Interventions

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bladder cycling

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes