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Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

2026年5月30日 更新者：Hany Fathy Badawy, MD、Beni-Suef University

Impact of Initial Drainage Method on Flexible Ureteroscopy Outcomes in Patients Presenting With Calculous Anuria: A Multicenter Prospective Randomized Controlled Trial

Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes.

This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a multicenter prospective randomized controlled trial comparing two emergency drainage strategies before definitive flexible ureteroscopy/retrograde intrarenal surgery in patients presenting with calculous anuria.

Adult patients with calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney will be assessed for eligibility. Eligible participants will be randomized in a 1:1 ratio to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage. Randomization will be performed using a computer-generated random sequence, with allocation concealment using sequentially numbered opaque sealed envelopes.

Participants assigned to the JJ stent group will undergo emergency retrograde placement of a 6 Fr JJ ureteral stent under cystoscopic guidance. Participants assigned to the percutaneous nephrostomy group will undergo emergency ultrasound-guided placement of an 8 Fr nephrostomy tube. After drainage, participants will be monitored for urine output recovery, renal functional improvement, symptom relief, and clinical stabilization.

Definitive flexible ureteroscopy/retrograde intrarenal surgery will be scheduled after renal functional improvement, clinical stabilization, and negative or appropriately treated urine culture. The definitive procedure will be performed using a standardized operative strategy. Ureteral access sheath use, successful insertion, need for adjunctive ureteral maneuvers, operative time, laser time, fluoroscopy time, postoperative stenting, complications, and hospital stay will be recorded.

The primary outcome is renal functional recovery after initial drainage and definitive surgery, assessed using serial serum creatinine measurements at presentation, 24 to 48 hours after drainage, before definitive surgery, postoperative day 1, and follow-up. Secondary outcomes include first-session definitive surgery success, stone-free rate, technical operative variables, intraoperative and postoperative complications, microbiological culture patterns, and predictors of surgical success or postoperative complications.

Participants will be followed for approximately one month after definitive surgery by clinical assessment, laboratory evaluation, and imaging for assessment of renal function, complications, and stone clearance.

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • エジプト
      • Tanta、エジプト
        • 募集
        • Department of Urology- Tanta University Hospitals
        • コンタクト：
        • 主任研究者：
          • I Elmaadawy, MD
    • Beni Suweif Governorate
      • Banī Suwayf、Beni Suweif Governorate、エジプト
        • 募集
        • Department of Urology- Beni-Suef University Hospitals
        • コンタクト：
        • 主任研究者：
          • Hany F Badawy, MD
    • Minya Governorate
      • Minya、Minya Governorate、エジプト
        • 募集
        • Department of Urology- Minia University Hospitals
        • コンタクト：
          • M Abdelmalek, MD
          • 電話番号：+20 11 00464753
        • 主任研究者：
          • M Abdelmalek, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Calculous anuria secondary to a single upper ureteral stone.
  • Solitary functioning kidney, whether anatomical or functional.
  • Single upper ureteral stone confirmed by non-contrast computed tomography.
  • Stone size from 6 mm to 20 mm in maximum diameter.
  • Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
  • Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
  • Documented renal functional improvement and clinical stabilization before definitive RIRS.
  • Negative or appropriately treated urine culture before definitive RIRS.
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Multiple stones or bilateral stones not fitting the solitary-kidney study design.
  • Renal pelvic, distal ureteral, or multiple ipsilateral stones.
  • Stone burden greater than 20 mm.
  • Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
  • Pyonephrosis requiring a non-randomized drainage decision.
  • Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
  • Previous ipsilateral ureteral reconstructive surgery.
  • Uncorrected coagulopathy.
  • Pregnancy.
  • Genitourinary malignancy.
  • Inability to complete follow-up.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：JJ Ureteral Stent Drainage Group
Participants randomized to this arm will undergo emergency retrograde placement of a 6 Fr double-J ureteral stent under cystoscopic guidance for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
手順：Initial JJ Ureteral Stent Drainage
Retrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
アクティブコンパレータ：Percutaneous Nephrostomy Drainage Group
Participants randomized to this arm will undergo emergency ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
手順：Initial Percutaneous Nephrostomy Drainage
Ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

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
Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS
時間枠：From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
Serum creatinine will be measured in mg/dL at 24-48 hours after initial drainage and on postoperative day 1 after definitive tratment of stone by retrograde intrarenal surgery. The primary outcome will compare the change in serum creatinine from the post-drainage value to the post-RIRS value between the JJ ureteral stent drainage group.
From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS

二次結果の測定

結果測定
メジャーの説明
時間枠
First-Session Definitive RIRS Success Rate
時間枠：During the definitive RIRS procedure
First-session definitive RIRS success will be defined as successful completion of flexible ureteroscopy/retrograde intrarenal surgery for the target upper ureteral stone in the planned first definitive session without the need to abort the procedure or schedule an additional unplanned definitive stone procedure during the same treatment pathway. The proportion of participants achieving first-session success will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure
Stone-Free Rate After Definitive RIRS
時間枠：4 weeks after definitive RIRS
Stone-free rate will be defined as the proportion of participants with no detectable residual target stone fragment on follow-up non-contrast computed tomography performed 4 weeks after definitive flexible ureteroscopy/retrograde intrarenal surgery. Stone-free rate will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group
4 weeks after definitive RIRS
During the definitive RIRS procedure
時間枠：During the definitive RIRS procedure
Total operative time will be measured in minutes from insertion of the cystoscope or ureteroscope to completion of the definitive flexible ureteroscopy/retrograde intrarenal surgery procedure. Mean or median operative time will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure
Need for Ureteral Stenting After Definitive RIRS
時間枠：At the end of the definitive RIRS procedure
The need for postoperative ureteral stent placement after definitive flexible ureteroscopy/retrograde intrarenal surgery will be recorded. The proportion of participants requiring postoperative stenting will be compared between both drainage groups
At the end of the definitive RIRS procedure
Intraoperative Complications During Definitive RIRS
時間枠：During the definitive RIRS procedure
Intraoperative complications will include ureteral mucosal injury, false passage, ureteral perforation, bleeding affecting visualization, and procedure interruption. The incidence of intraoperative complications will be compared between both drainage groups.
During the definitive RIRS procedure
Postoperative Infectious Complications After Definitive RIRS
時間枠：From definitive RIRS to 4 weeks after definitive RIRS
Postoperative infectious complications will include fever greater than 38°C, systemic inflammatory response syndrome, or sepsis after definitive flexible ureteroscopy/retrograde intrarenal surgery. The incidence of postoperative infectious complications will be compared between both drainage groups.
From definitive RIRS to 4 weeks after definitive RIRS

その他の成果指標

結果測定
メジャーの説明
時間枠
Ureteral Access Sheath Insertion Success Rate
時間枠：During the definitive RIRS procedure
Ureteral access sheath insertion success will be defined as successful placement of a ureteral access sheath during definitive flexible ureteroscopy/retrograde intrarenal surgery without the need for active ureteral dilatation, semirigid ureteroscopy assistance, or abandonment of sheath placement. The proportion of successful ureteral access sheath insertion will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Beni-Suef University

捜査官

  • 主任研究者：Hany F Badawy, MD、Faculty of medicine BeniSuef University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月6日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年5月30日

QC基準を満たした最初の提出物

2026年5月30日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月30日

最終確認日

2026年5月1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

  • FMB050526-ANURIA-RIRS

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?

いいえ

IPD プランの説明

Individual participant data will not be shared because the study includes individual-level clinical, laboratory, radiological, operative, and microbiological data from patients presenting with an emergency urological condition. Only aggregated and de-identified study results will be reported. Any future sharing of individual participant data would require additional approval from the Research Ethics Committee and an appropriate data-sharing agreement.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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