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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 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

87

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Dr.Mohsin Memon, FCPS

Luoghi di studio

    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Reclutamento
        • Sindh Institute of Urology and Transplantation (SIUT)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bladder Capacity
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 febbraio 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SIUT-ERC-2025/A-611

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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