Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones
Comparison of Treatment Efficacy of Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy in Patients With Upper Ureteric Stones: A Randomized Controlled Trial
Upper ureteric stones can be treated using extracorporeal shock wave lithotripsy or ureteroscopy. Extracorporeal shock wave lithotripsy breaks the stone using shock waves delivered from outside the body, whereas ureteroscopy involves passing a small instrument through the urinary tract to locate and fragment the stone.
This randomized controlled trial compared the effectiveness and safety of these two treatments in adults with a single upper ureteric stone smaller than 10 mm and a stone density of 1000 Hounsfield units or less. Participants were assigned to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy. The main outcome was complete stone clearance on non-contrast computed tomography four weeks after completion of the assigned treatment. Pain relief, number of treatment sessions and treatment-related complications were also assessed.
調査の概要
詳細な説明
This single-centre, randomized, parallel-group controlled trial was conducted in the Department of Urology, Federal Postgraduate Medical Institute, Shaikh Zayed Hospital, Lahore, Pakistan. The objective was to compare the treatment efficacy and short-term safety of extracorporeal shock wave lithotripsy (ESWL) with semirigid ureteroscopy (URS) in patients presenting with an upper ureteric stone.
A total of 100 participants aged 18-75 years were enrolled. Eligible participants had a single unilateral upper ureteric stone located above the sacroiliac joint. The stone was confirmed on non-contrast computed tomography of the kidneys, ureters and bladder, measured less than 10 mm in maximum diameter and had a density of 1000 Hounsfield units or less. Participants were randomized in a 1:1 ratio by lottery, with 50 participants assigned to each treatment group.
Participants assigned to ESWL were treated using the MODULITH SLX-F2 lithotripter. Shock waves were delivered at a rate of 60-120 shocks per minute, with an energy setting of 1-9 kV and approximately 2500-3000 shocks per session. Each session lasted approximately 30-60 minutes. A maximum of three sessions was permitted, with an interval of at least 48 hours between successive sessions.
Participants assigned to URS underwent semirigid ureteroscopy under general anesthesia using a 6.5-7.5 Fr semirigid ureteroscope. Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe. Stone fragments were removed using a Dormia basket or grasping forceps when required. A double-J ureteric stent was inserted in every participant undergoing URS and was subsequently removed according to clinical assessment.
The primary outcome was complete stone clearance, assessed using non-contrast computed tomography four weeks after completion of the assigned treatment. Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter. A participant requiring an additional stone-removal procedure before the four-week assessment was classified as having treatment failure.
Secondary outcomes included the number of ESWL sessions required, pain relief, immediate procedure-related complications and complications occurring during the four-week follow-up period.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Lahore、パキスタン、54810
- Sheikh Zayed Hospital
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-
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:
- Male or female participant aged 18 to 75 years Single unilateral upper ureteric stone located above the sacroiliac joint Stone confirmed by non-contrast computed tomography of the kidneys, ureters and bladder Stone maximum diameter less than 10 mm Stone density of 1000 Hounsfield units or less Written informed consent provided Willing and able to complete the assigned treatment and four-week follow-up
Exclusion Criteria:
- Solitary functioning kidney Bilateral ureteric stones Active urinary tract infection Deranged renal function Stone maximum diameter of 10 mm or greater Stone density greater than 1000 Hounsfield units Unable or unwilling to complete the assigned treatment or four-week follow-up
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：なし（オープンラベル）
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：Extracorporeal Shock Wave Lithotripsy
Participants received extracorporeal shock wave lithotripsy using the MODULITH SLX-F2 lithotripter.
A maximum of three sessions was permitted, with an interval of at least 48 hours between sessions.
|
ESWL was performed using the MODULITH SLX-F2 lithotripter at 60-120 shocks per minute, an energy setting of 1-9 kV and approximately 2500-3000 shocks per session.
Each session lasted approximately 30-60 minutes.
Up to three sessions were permitted, with at least 48 hours between sessions.
|
|
アクティブコンパレータ：Semirigid Ureteroscopy
Participants underwent semirigid ureteroscopy under general anesthesia with pneumatic stone fragmentation.
Stone fragments were removed when required, and a double-J ureteric stent was inserted in all participants.
|
Semirigid ureteroscopy was performed under general anesthesia using a 6.5-7.5 Fr ureteroscope.
Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe.
Fragments were removed using a Dormia basket or grasping forceps when required.
A double-J ureteric stent was inserted in every participant and subsequently removed according to clinical assessment.
|
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 |
|---|---|---|
|
Complete Stone Clearance
時間枠：4 weeks after completion of the assigned treatment
|
Number of participants with complete stone clearance on non-contrast computed tomography of the kidneys, ureters and bladder.
Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter.
Participants requiring an additional stone-removal procedure before assessment were classified as treatment failures.
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4 weeks after completion of the assigned treatment
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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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Number of ESWL Sessions Required
時間枠：Immediately after completion of the final ESWL treatment session
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Number of extracorporeal shock wave lithotripsy sessions received by each participant assigned to the ESWL arm.
Participants could receive a maximum of three sessions, with an interval of at least 48 hours between successive sessions.
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Immediately after completion of the final ESWL treatment session
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- TERC/SC/INT/2025/570
- Technical and Ethical Review C (その他の識別子：Shaikh Zayed Federal Postgraduate Medical Institute)
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- ICF
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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