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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)

2026년 4월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

87

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Dr.Mohsin Memon, FCPS

연구 장소

    • Sindh
      • Karachi, Sindh, 파키스탄, 74200
        • 모병
        • Sindh Institute of Urology and Transplantation (SIUT)
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Bladder Capacity
기간: 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
기간: 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)

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 2월 2일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 4월 29일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 29일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SIUT-ERC-2025/A-611

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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