Predicting BPH Surgery Outcomes Using a Preoperative Scoring System
Development and Clinical Application Value of a Predictive Scoring System for Postoperative Outcomes Following Transurethral Resection of the Prostate Based on Preoperative Multidimensional Objective Indicators
This study aims to develop and validate a preoperative predictive scoring system for surgical outcomes in patients with benign prostatic hyperplasia (BPH) undergoing prostate surgery (including but not limited to transurethral resection of the prostate, laser enucleation, photoselective vaporization, or robot-assisted simple prostatectomy).
It is a multicenter retrospective study involving patients from four hospitals in China. Preoperative multidimensional objective indicators, including clinical data, prostate MRI parameters, and urodynamic measurements, will be collected. The primary outcome is a favorable surgical response defined by a postoperative-to-preoperative International Prostate Symptom Score (IPSS) ratio ≤ 0.5 at 6 months after surgery.
Multivariable logistic regression, restricted cubic splines, and bootstrap internal validation will be used to construct and evaluate the scoring system. The goal is to provide an objective, individualized tool for optimizing surgical decision-making in BPH patients.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yong Wei
- 電話番号：13960985927
- メール：drzhuzh@163.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:
- - Postoperative pathological diagnosis of benign prostatic hyperplasia (BPH)
- Completion of pelvic or prostate magnetic resonance imaging (MRI) plain scan within 1 month before surgery
- Completion of urodynamic study within 1 month before surgery
- Completion of International Prostate Symptom Score (IPSS) both before and after surgery
- Complete and retrievable clinical and pathological data
- Generally good condition without infection, autoimmune disease, hematologic disease, or other malignancies
- Complete follow-up data with follow-up duration of at least 6 months after surgery
Exclusion Criteria:
- - Concomitant prostate cancer or other malignancies
- Prior prostate surgery or pelvic radiotherapy
- Severe cardiac, pulmonary, hepatic, or renal insufficiency precluding tolerance of surgery
- Intraoperative or postoperative severe complications affecting efficacy assessment
- Follow-up duration less than 6 months or missing key data
- Poor patient compliance precluding completion of necessary assessments and follow-up
- Incomplete clinical, imaging, urodynamic, or pathological data, or loss to 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
コホートと介入
グループ/コホート |
|---|
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BPH Patients Undergoing Prostate Surgery
Patients with BPH who underwent prostate surgery (various techniques including TURP, laser enucleation, PVP, or RASP) between Jan 2020 and Aug 2025 across four centers.
Preoperative MRI and urodynamic data collected.
Primary outcome: IPSS ratio ≤0.5 at 6 months post-surgery.
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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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Proportion of patients with favorable surgical response at 6 months post-surgery
時間枠：6 months after surgery
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Favorable surgical response is defined as a ratio of postoperative International Prostate Symptom Score (IPSS) to preoperative IPSS ≤ 0.5 at 6 months after surgery.
IPSS assesses lower urinary tract symptoms, with scores ranging from 0 to 35 (higher scores indicating more severe symptoms).
A ratio ≤ 0.5 represents at least 50% improvement from baseline.
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6 months after surgery
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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 (推定)
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
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
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。