Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled Trial
Acute calculous anuria is a urological emergency caused by ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Urgent decompression of the upper urinary tract is required to restore urine drainage and prevent further renal impairment.
This prospective randomized double-blind controlled trial will evaluate whether intravesical aminophylline can facilitate urgent retrograde ureteral stenting in adult patients with acute calculous anuria due to ureteral stones. Eligible patients will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or placebo saline before attempted retrograde Double-J ureteral stent placement.
The primary outcome is technical success, defined as successful placement of a Double-J ureteral stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary outcomes include stenting time, intraoperative complications, renal function recovery, postoperative pain, analgesic requirement, and the need for alternative drainage.
調査の概要
状態
詳細な説明
This is a prospective, randomized, double-blind, controlled trial conducted at the Department of Urology, Beni-Suef University Hospital.
The study will include adult patients aged 18 years or older presenting with acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Obstruction will be confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract. Eligible patients will have clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and elevated serum creatinine.
After eligibility assessment and informed consent, participants will be randomly allocated in a 1:1 ratio to one of two groups.
Participants in the aminophylline group will receive intravesical instillation of 250 mg aminophylline diluted in normal saline to a total volume of 160 mL. Participants in the control group will receive placebo intravesical instillation using normal saline with the same total volume. The study solution will be prepared by a nurse who is not involved in the operation to maintain blinding of the patient and the operating surgeon.
Under general or spinal anesthesia, the patient will be placed in the lithotomy position. A cystoscope will be introduced and the bladder will be emptied. The assigned intravesical solution will then be instilled into the bladder and retained for 5 minutes before proceeding with retrograde ureteral stenting. Under fluoroscopic guidance, a guidewire will be advanced through the ureteric orifice in an attempt to bypass the obstructing ureteral stone. If successful, a Double-J ureteral stent will be advanced over the guidewire and positioned across the obstruction.
The primary endpoint is technical success of retrograde ureteral stenting, defined as successful placement of the Double-J stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary endpoints include time required for successful stent placement, intraoperative complications, serum creatinine changes at 24, 48, and 72 hours after decompression, postoperative pain score, analgesic requirement, and the need for alternative drainage after failed retrograde stenting.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
研究連絡先のバックアップ
- 名前：Mahmoud Abdallah, MD
- 電話番号：+201211874080
- メール：Drhanyfathy86@GMAIL.COM
研究場所
-
-
Beni Suweif Governorate
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Banī Suwayf、Beni Suweif Governorate、エジプト
- 募集
- Department of Urology- Beni-Suef University Hospitals
-
コンタクト：
- Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
-
コンタクト：
- Mahmoud Abdallah, MD
- 電話番号：+201211874080
- メール：Drhanyfathy86@GMAIL.COM
-
主任研究者：
- Hany F Badawy, MD
-
-
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
説明
Inclusion Criteria:
- Patients aged 18 years or older.
- Diagnosis of acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney.
- Obstruction confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract.
- Clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and serum creatinine >2 mg/dL.
- Ability to provide written informed consent.
Exclusion Criteria:
- Known hypersensitivity to aminophylline, theophylline, or other methylxanthines.
- Evidence of active urinary tract infection or urosepsis.
- Previous history of ureteral stricture or major urinary tract reconstructive surgery.
- Hemodynamic instability requiring immediate life-saving measures before urological intervention.
- Pregnancy.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intravesical Aminophylline
Participants will receive intravesical instillation of 250 mg aminophylline diluted with normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
|
Aminophylline 250 mg diluted with normal saline to a total intravesical instillation volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
|
|
プラセボコンパレーター：Placebo Saline
Participants will receive intravesical placebo instillation using normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
|
Placebo intravesical instillation using normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
|
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 |
|---|---|---|
|
Technical Success of Retrograde Double-J Ureteral Stent Placement
時間枠：During the index urgent retrograde stenting procedure
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Technical success will be defined as successful placement of a Double-J ureteral stent across the obstructing ureteral stone during the initial urgent retrograde stenting procedure without the need for percutaneous nephrostomy.
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During the index urgent retrograde stenting procedure
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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 |
|---|---|---|
|
Retrograde Stenting Attempt Time
時間枠：During the index urgent retrograde stenting procedure
|
Time will be measured in minutes from the start of the retrograde stenting attempt after the 5-minute intravesical dwell time until successful final Double-J stent positioning or the decision to stop the retrograde attempt because of technical failure.
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During the index urgent retrograde stenting procedure
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Intraoperative Complication Rate
時間枠：During the index urgent retrograde stenting procedure
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Proportion of participants who experience intraoperative procedure-related complications, including ureteral mucosal injury, ureteral perforation, bleeding, guidewire false passage, or other procedure-related adverse events.
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During the index urgent retrograde stenting procedure
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Serum Creatinine Change During the First 72 Hours After Decompression
時間枠：Baseline, 24 hours, 48 hours, and 72 hours after decompression
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Serum creatinine will be measured before decompression and at 24, 48, and 72 hours after the procedure to assess early renal function recovery.
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Baseline, 24 hours, 48 hours, and 72 hours after decompression
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Postoperative Pain Score During the First 24 Hours
時間枠：Every 4 hours during the first 24 hours postoperatively
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Postoperative pain will be assessed using a 10-point Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Scores will be recorded every 4 hours during the first 24 hours after recovery from anesthesia.
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Every 4 hours during the first 24 hours postoperatively
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Hany F Badawy, MD、Beni-Suef University
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC07042026Ahmed
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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