Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Evaluation of the Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Indwelling Catheters Due to Urinary Retention: A Multicenter Study of the Minimally Invasive Urology Society
調査の概要
詳細な説明
This study is designed as a prospective, observational, multicenter, cohort study conducted under the academic coordination of the Minimally Invasive Urology Society. The study will analyze data from multiple participating centers across Turkey. All clinical parameters will be standardized and recorded in a secure, electronic environment. Preoperative data include patient demographics, catheter duration and baseline urinary scores. Intraoperative data focus on surgical duration and energy parameters. Postoperative data track recovery, complication rates according to the Clavien-Dindo classifications and functional outcomes like flow rates (Qmax), International Prostate Symptom Score (IPSS), post-void residual volume (PVR) at 3 months.
By integrating data from diverse clinical settings, this multicenter study aims to establish a clearer understanding of the optimal timing of surgery, ultimately improving clinical decision-making for patients with urinary retention.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Suleyman Oner, MD
- 電話番号：+905544064491
- メール：dr.suleymanoner@gmail.com
研究連絡先のバックアップ
- 名前：Cemil Aydin, Professor
- 電話番号：+905326960378
- メール：cemilaydin78@yahoo.com.tr
研究場所
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Eskişehir
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Eskişehir、Eskişehir、トルコ（Türkiye）、26040
- 募集
- Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
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コンタクト：
- Suleyman Oner, MD
- 電話番号：+905544064491
- メール：dr.suleymanoner@gmail.com
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients undergoing laser enucleation of the prostate, including HoLEP, ThuLEP or ThuFLEP procedures, who have an indwelling urinary catheter due to pre-operative urinary retention.
Exclusion Criteria:
- Patients with a diagnosis of neurogenic bladder or prostate cancer.
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 |
|---|---|
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Short-term Catheterization Group
Patients who have been using an indwelling urinary catheter for less than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)
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Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center.
The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue.
All surgeries are performed by urologists according to established surgical protocols.
他の名前：
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Long-term Catheterization Group
Patients who have been using an indwelling urinary catheter for more than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)
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Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center.
The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue.
All surgeries are performed by urologists according to established surgical protocols.
他の名前：
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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 |
|---|---|---|
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Change in International Prostate Symptom Score (IPSS)
時間枠：Baseline and 3 months postoperatively
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Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 to 5. Total score ranges from 0 to 35. Higher scores indicate more severe urinary symptoms (0-7: mild, 8-19: moderate, 20-35: severe). |
Baseline and 3 months postoperatively
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Change in Peak Urinary Flow Rate (Qmax)
時間枠：Baseline and 3 months postoperatively.
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Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Peak urinary flow rate is measured in milliliters per second (mL/s) using uroflowmetry to assess the improvement in urinary flow after the surgical procedure. |
Baseline and 3 months postoperatively.
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Change in Post-Void Residual Volume (PVR)
時間枠：Baseline and 3 months postoperatively.
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Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP): Post-void residual volume is the amount of urine remaining in the bladder after voiding, measured in milliliters (mL) via transabdominal ultrasound or catheterization. |
Baseline and 3 months postoperatively.
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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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Postoperative Complication Rate
時間枠：From the date of surgery up to 3 months postoperatively.
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The frequency and severity of surgical complications occurring after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP). Complications will be categorized and graded using the Clavien-Dindo Classification of Surgical Complications. This scale ranges from Grade I (minor deviations from the normal postoperative course) to Grade V (death of the patient). Higher grades indicate a worse outcome (more severe complications). Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Complications requiring pharmacological treatment Grade III: Complications requiring surgical, endoscopic, or radiological intervention Grade IV: Life-threatening complications requiring intensive care unit (ICU) management Grade V: Death of the patient. |
From the date of surgery up to 3 months postoperatively.
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協力者と研究者
協力者
捜査官
- スタディチェア：Suleyman Oner, MD、Eskisehir Osmangazi University Faculty of Medicine Hospital
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
- E-25403353-050.04-260029122
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
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