Bladder Cycling, Defunctionalized Bladder
Conditions
Keywords
bladder cycling, defunctionalized bladder
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.
Interventions
PROCEDUREbladder 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.
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measuring bladder size | 3 months | measuring bladder size by ACUG |
Secondary
| Measure | Time frame |
|---|---|
| increasing bladder size to facilitate uretrovesical reimplantation during renal transplantationn | 3 months |
Countries
Egypt
Outcome results
None listed