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

NCT07570771 | Recruiting

• 1 other identifier: SIUT-ERC-2025/A-611
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-Stage Renal Disease Requiring Haemodialysis; Bladder Dysfunction

Keywords

Dialysis Duration; Bladder Capacity; Bladder Compliance; Renal Transplant Candidates

Outcome Measures

Primary Outcomes (2)

• 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.

  At time of urodynamic evaluation (baseline)

• 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.

  At time of urodynamic evaluation (baseline)

Secondary Outcomes (3)

• Post-Void Residual Volume

  At baseline evaluation

• Maximum Urinary Flow Rate (Qmax)

  At baseline evaluation

• At baseline evaluation

  At baseline evaluation

Study Arms (2)

Oliguric Patients

Patients with end-stage renal disease (ESRD) on maintenance dialysis with residual urine output between 100-400 mL/day undergoing observational assessment of bladder capacity and compliance using urodynamic studies.

Diagnostic Test: Observational Assessment

Anuric Patients

Patients with end-stage renal disease (ESRD) on maintenance dialysis with urine output less than 100 mL/day undergoing observational assessment of bladder capacity and compliance using urodynamic studies.

Diagnostic Test: Observational Assessment

Interventions

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.

Anuric Patients; Oliguric Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with diabetes mellitus
• Patients with neurogenic bladder
• Patients with prior urological surgeries
• Patients with active urinary tract infection
• Patients with pre-existing lower urinary tract symptoms before dialysis
• Patients on medications affecting lower urinary tract function
• Patients with neurological or systemic diseases affecting bladder function

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation (SIUT)

Karachi, Sindh, 74200, Pakistan

RECRUITING

Central Study Contacts

Dr. Anum Fatima Parekh, FCPS

CONTACT

+92-333-3305227; anum.parekh@yahoo.com

Dr.Mohsin Memon, FCPS

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 01 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)