IMPACT OF DIALYSIS DURATION AND DIURESIS ON BLADDER CAPACITY AND COMPLIANCE IN END STAGE RENAL DISEASE PATIENTS AWAITING RENAL TRANSPLANT

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSindh Institute of Urology and Transplantation

About this trial

Patients with end-stage renal disease (ESRD) who are on dialysis for a long time may experience bladder problems as their urine output decreases and normal bladder filling is lacking. As a result, bladder capacity may be reduced and compliance may deteriorate, which can impact the success of kidney transplantation.

Our prospective observational study is designed to investigate how dialysis duration and residual urine output (diuresis) influence bladder capacity and compliance in ESRD patients who are waiting for kidney transplantation. The adult patients undergoing regular dialysis will be assessed clinically, and they will also be subjected to laboratory tests, imaging, and urodynamic studies.

Through this study, we aim to determine the frequency of bladder malfunction and its correlation with the length of dialysis and the amount of urine excretion. The results might enhance the pre-transplant workup and offer a basis for urological post-transplantation management that could minimize complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-65 years diagnosed with end-stage renal disease (ESRD)

Patients on maintenance dialysis for a duration of 6 to 24 months

ESRD secondary to non-urological causes

Patients awaiting renal transplantation

Disqualifiers

Patients with diabetes mellitus

Patients with neurogenic bladder

Patients with prior urological surgeries

Patients with active urinary tract infection

Trial population

Adult patients with end-stage renal disease (ESRD) on maintenance dialysis and awaiting renal transplantation at Sindh Institute of Urology and Transplantation (SIUT), Karachi.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Assessment

    Diagnostic test

    This is a prospective observational study with no therapeutic or preventive intervention. Participants undergo clinical assessment, including evaluation of dialysis duration and residual urine output, along with laboratory investigations, imaging, and urodynamic studies to assess bladder capacity and compliance.

Treatment groups

87 Participants
are divided into 2 treatment groups
Group A: Oliguric Patients1 intervention
Group B: Anuric Patients1 intervention

Trial outcomes

Primary outcomes

1

Bladder Capacity

Bladder capacity is measured in milliliters (mL) using video urodynamic study (VUDS) at the time of evaluation, defined as the maximum cystometric capacity at which the patient is given permission to void.

Time frame
At time of urodynamic evaluation (baseline)
2

Bladder Compliance

Bladder compliance measured in mL/cm H₂O using a video-urodynamic study is calculated as the change in bladder volume divided by the change in detrusor pressure during the filling phase.

Time frame
At time of urodynamic evaluation (baseline)

Secondary outcomes

1

Post-Void Residual Volume

Measured in milliliters (mL) using ultrasound after voiding.

Time frame
At baseline evaluation
2

Maximum Urinary Flow Rate (Qmax)

Measured in mL/sec using uroflowmetry.

Time frame
At baseline evaluation
3

At baseline evaluation

Presence of lower urinary tract symptoms assessed clinically and recorded as a categorical variable (present or absent).

Time frame
At baseline evaluation

Other outcomes

Sponsors and contacts

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