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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Dysfunction; End-Stage Renal Disease Requiring Haemodialysis
• Intervention / Treatment: Diagnostic test: Observational Assessment

Detailed Description

End-stage renal disease (ESRD) is related to major changes in lower urinary tract functions, mainly due to decreased urine production and prolonged bladder inactivity during dialysis. Therefore, the bladder might shrink and get stiff, the muscle of the bladder can contract involuntarily, and other abnormalities of urine storage and voiding can be detected.

Such urodynamic changes have fairly good clinical relevance since impaired bladder function not only increases the susceptibility to urinary tract infections, but also to vesicoureteral reflux, and it can have negative effects on renal transplant outcomes.

Dialysis duration and loss of residual urine production capacity are recognized as the main factors affecting bladder function. Dialysis patients who have been on the treatment for a long time and are anuric will develop more bladder dysfunction and damage than those with preserved urine output.

This prospective observational study is planned to take place at Sindh Institute of Urology and Transplantation (SIUT), Karachi, Pakistan. Adult patients aged 18-65 years with end-stage renal disease on maintenance dialysis for 6 to 24 months and awaiting renal transplantation will be enrolled through consecutive sampling.

After getting the informed consents, demographic and clinical data will be recorded, such as age, gender, body mass index, cause of ESRD, duration of dialysis, and urine output, which will be measured by a frequency-volume chart. The initial work-up will include examination of the urine, urine culture, and ultrasound examination of the kidneys, ureters, and bladder with measurement of post-void residual volume.

All eligible patients will be further evaluated with cystoscopy, uroflowmetry, and video-urodynamic studies to assess bladder morphology and function. The main outcome variables are bladder capacity and bladder compliance, whereas secondary variables include maximum urinary flow rate (Qmax), post-void residual volume, and the presence of lower urinary tract symptoms.

The acquired data will be statistically analyzed using appropriate methods to identify possible relationships between dialysis duration, diuresis status, and bladder function parameters. This study is conducted with the aim to estimate the prevalence of clinically significant bladder dysfunction and to identify high-risk patients who may benefit from early urological intervention prior to renal transplantation.

• Study Type: Observational
• Enrollment (Estimated): 87

Contacts and Locations

• Study Contact: Name: Dr. Anum Fatima Parekh, FCPS; Phone Number: +92-333-3305227; Email: anum.parekh@yahoo.com
• Study Contact Backup: Name: Dr.Mohsin Memon, FCPS

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Recruiting
      • Sindh Institute of Urology and Transplantation (SIUT)
      • Contact: Anum Fatima Parekh, FCPS; Phone Number: +92-333-3305227; Email: anum.parekh@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Void Residual Volume	Measured in milliliters (mL) using ultrasound after voiding.	At baseline evaluation
Maximum Urinary Flow Rate (Qmax)	Measured in mL/sec using uroflowmetry.	At baseline evaluation
At baseline evaluation	Presence of lower urinary tract symptoms assessed clinically and recorded as a categorical variable (present or absent).	At baseline evaluation

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bladder Compliance; Dialysis Duration; Bladder Capacity; Renal Transplant Candidates
• Other Study ID Numbers: SIUT-ERC-2025/A-611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient confidentiality, institutional policies, and the absence of a formal data-sharing framework. All collected data will be securely stored and used only for the purposes of this study in accordance with ethical approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No