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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
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
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Dr. Anum Fatima Parekh, FCPS
- 전화번호: +92-333-3305227
- 이메일: anum.parekh@yahoo.com
연구 연락처 백업
- 이름: Dr.Mohsin Memon, FCPS
연구 장소
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Sindh
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Karachi, Sindh, 파키스탄, 74200
- 모병
- Sindh Institute of Urology and Transplantation (SIUT)
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연락하다:
- Anum Fatima Parekh, FCPS
- 전화번호: +92-333-3305227
- 이메일: anum.parekh@yahoo.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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.
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bladder Capacity
기간: At time of urodynamic evaluation (baseline)
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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.
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At time of urodynamic evaluation (baseline)
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Bladder Compliance
기간: At time of urodynamic evaluation (baseline)
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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.
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At time of urodynamic evaluation (baseline)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Post-Void Residual Volume
기간: At baseline evaluation
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Measured in milliliters (mL) using ultrasound after voiding.
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At baseline evaluation
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Maximum Urinary Flow Rate (Qmax)
기간: At baseline evaluation
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Measured in mL/sec using uroflowmetry.
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At baseline evaluation
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At baseline evaluation
기간: At baseline evaluation
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Presence of lower urinary tract symptoms assessed clinically and recorded as a categorical variable (present or absent).
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At baseline evaluation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SIUT-ERC-2025/A-611
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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