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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Dr. Anum Fatima Parekh, FCPS
- 電話番号：+92-333-3305227
- メール：anum.parekh@yahoo.com
研究連絡先のバックアップ
- 名前：Dr.Mohsin Memon, FCPS
研究場所
-
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Sindh
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Karachi、Sindh、パキスタン、74200
- 募集
- Sindh Institute of Urology and Transplantation (SIUT)
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コンタクト：
- Anum Fatima Parekh, FCPS
- 電話番号：+92-333-3305227
- メール：anum.parekh@yahoo.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bladder Capacity
時間枠：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.
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At time of urodynamic evaluation (baseline)
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Bladder Compliance
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post-Void Residual Volume
時間枠：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)
時間枠：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
時間枠：At baseline evaluation
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Presence of lower urinary tract symptoms assessed clinically and recorded as a categorical variable (present or absent).
|
At baseline evaluation
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SIUT-ERC-2025/A-611
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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