Outcome of Renal Transplant on a Defunctionalized Bladder

Outcome of Renal Transplant on a Defunctionalized Bladder. A Randomized Controlled Trial

In this study, investigators will prospectively 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 Overview

• Status: Unknown
• Conditions: Renal Transplantation Into a Defunctionalized Bladder
• Intervention / Treatment: Behavioral: bladder recycling

Detailed Description

Study population:

The study will include patients maintained on hemodialysis for more than 12 months, have oliguria or anuria, reduced bladder capacity, have no history of lower urinary tract dysfunction and have no evidence of urological cause of renal failure. Patients with history of lower urinary tract symptoms before developing renal failure and those with lower urinary tract disease resulting in renal failure will be excluded.

Study design:

It is a randomized controlled trial comparing the outcome of programmed bladder cycling before the time of renal transplantation and direct transplantation without bladder cycling in patients with defunctionalized bladder. Patients, who meet the inclusion criteria, will be randomly allocated into two groups. The first group will undergo renal transplantation on the defunctionalized bladder without bladder recycling. The second group will undergo renal transplantation after bladder recycling.

Measurements:

All patients will be diagnosed by proper history taking, cystoscopy, ascending cystogram and cystometry in order to confirm the diagnosis of reduced bladder capacity and exclude any organic or neurological cause. Bladder recycling will be done by the patient after proper education. It will be 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 300 cc of sterile water for 2 hours. Any associated complications will be reported and the time needed to reach the due bladder capacity will be recorded. The procedure of renal transplantation will be carried out according to the hospital protocol and the ureteroneocystostomy will be done by a non-stented Leich Gregoir technique.

Assuming that the bladder will regain its activity and full capacity after 8 weeks of transplantation, all patients will be assessed 3 months after transplantation by the following:

1. IPSS questionnaire in order to evaluate the lower urinary tract symptoms.
2. Ascending cystogram.
3. Cystometry.
4. Graft function.

Outcome:

The primary outcome is to evaluate whether bladder recycling is efficient to restore bladder function prior to renal transplantation in terms of IPSS score, and urodynamic evaluation. The secondary outcome is to evaluate the differences in graft and patients outcome between groups.

Power calculation and Statistical analysis:

We hypothesized that at 3 months postoperatively; recipients without bladder training will be non-inferior to those underwent bladder training in terms of cystometric capacity. Based on this, to achieve a difference in mean cystometric capacity of 50 cc in favor of bladder training patients, 16 patients in each group are required to achieve a power of 80% and an α error of 0.05. Statistical power is determined using medcalc version 12.5.0.0 software and all statistical analyses will be performed using IBM version 20 statistical software.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Dakahlia
    • Al Manşūrah, El Dakahlia, Egypt, 35516
      • Recruiting
      • Urology and nephrology center
      • Contact: Mohamed H Zahran, Dr; Phone Number: 0502202638; Email: zahranmha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients maintained on hemodialysis for more than 12 months
• have oliguria or anuria
• reduced bladder capacity
• have no history of lower urinary tract dysfunction and have no evidence of urological cause of renal failure.

Exclusion Criteria:

• Patients with history of lower urinary tract symptoms before developing renal failure and
• those with lower urinary tract disease resulting in renal failure will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: renal transplant without bladder recycling; the patients allocated to this arm and met inclusion criteria will undergo renal transplant without prior recycling of the bladder
ACTIVE_COMPARATOR: renal transplantation with bladder recycling; the patients allocated in this arm will undergo bladder recycling prior to renal transplantation	Behavioral: bladder recycling; Bladder recycling will be done by the patient after proper education. It will be 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 300 cc of sterile water for 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of bladder function after recycling	to evaluate whether bladder recycling is efficient to restore bladder function prior to renal transplantation by urodynamic evaluation and ascending cystogram to measure the bladder capacity in cm	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
voiding function after renal transplantation	IPSS questionnaire in order to evaluate the lower urinary tract symptoms score ( score range from 0-35); Ascending cystogram.( capacity in cm, presence of reflux, postvoiding residual urine); Cystometry ( capacity in cm)	3 months after renal transplantation
graft function	creatinine clearance and estimated GFR by renography ( ml/min/1.73 m2)	1 year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: January 23, 2016
• First Posted (ESTIMATE): January 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: renal transplantation; defunctionalized bladder; bladder recycling
• Other Study ID Numbers: Zahran MH3182015