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

29. april 2026 oppdatert av: Dr. Anum Fatima Parekh, Sindh Institute of Urology and Transplantation

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

87

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

  • Navn: Dr.Mohsin Memon, FCPS

Studiesteder

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Rekruttering
        • Sindh Institute of Urology and Transplantation (SIUT)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk 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.
Diagnostisk 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bladder Capacity
Tidsramme: At time of urodynamic evaluation (baseline)
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
Tidsramme: At time of urodynamic evaluation (baseline)
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)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

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Sponsor

Sindh Institute of Urology and Transplantation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. februar 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • SIUT-ERC-2025/A-611

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

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