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LUTS/BPHにおける薬物療法への反応を予測するための超音波IPP

2026年9月27日 更新者:Mustafa mohamed esmail aboalmagd、Ain Shams University

下部尿路症状を有する良性前立腺肥大症患者における薬物療法への反応予測における膀胱内前立腺突出の超音波評価の役割

This prospective cohort study evaluated whether transabdominal ultrasound measurement of intravesical prostatic protrusion predicts symptom severity and response to medical therapy in men aged 50 years or older with lower urinary tract symptoms secondary to benign prostatic hyperplasia. At baseline, participants underwent clinical evaluation, laboratory assessment including prostate-specific antigen, symptom scoring using the International Prostate Symptom Score and quality of life index, uroflowmetry, and transabdominal ultrasonography to measure prostate volume, bladder parameters, post-void residual urine, detrusor wall thickness, and intravesical prostatic protrusion. Participants were grouped by intravesical prostatic protrusion grade (less than 5 millimetres, 5 to 10 millimetres, and greater than 10 millimetres) and were followed for six months with reassessments at three and six months to evaluate response to medical therapy and identify patients who required escalation of treatment or surgical intervention.

調査の概要

研究の種類

観察的

入学 (実際)

130

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。

研究場所

    • Cairo Governorate
      • Cairo、Cairo Governorate、エジプト、11511
        • Ain Shams University Hospitals

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

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

男

サンプリング方法

非確率サンプル

調査対象母集団

Men aged 50 years or older with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia attending urology outpatient services at Ain Shams University Hospitals.

説明

Inclusion Criteria:

  • Male participants aged 50 years or older.
  • Lower urinary tract symptoms secondary to benign prostatic hyperplasia.
  • Moderate to severe symptoms with International Prostate Symptom Score 15 to 35.
  • Prostate volume 30 to 100 millilitres.
  • Maximum urinary flow rate less than 15 millilitres per second.
  • No hydronephrosis due to bladder outlet obstruction.
  • Normal prostate-specific antigen or normal free-to-total prostate-specific antigen ratio.

Exclusion Criteria:

  • History of prostate, bladder, or lower urinary tract surgery.
  • Neurological disease affecting lower urinary tract function.
  • Active urinary tract infection and/or symptomatic urinary tract stones.
  • Post-void residual urine volume greater than 200 millilitres.
  • Urethral stricture.
  • Prostate cancer or bladder cancer.

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

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
IPP Grade I (<5 mm)

Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion less than 5 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.

Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol.

Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

IPP Grade II (5-10 mm)

Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion 5 to 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.

Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol.

Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

IPP Grade III (>10 mm)

Participants with lower urinary tract symptoms secondary to benign prostatic hyperplasia and intravesical prostatic protrusion greater than 10 millimetres measured by transabdominal ultrasonography at bladder volume 100-200 millilitres. Participants received medical therapy as prescribed by the treating urologist and were followed for 6 months with assessments at baseline, 3 months, and 6 months including International Prostate Symptom Score/quality of life, uroflowmetry, and ultrasound parameters.

Transabdominal ultrasonography; TAUS; Ultrasound IPP measurement Intervention Description: Intravesical prostatic protrusion was measured using transabdominal ultrasonography in the midsagittal plane at a bladder volume of approximately 100-200 millilitres. The measurement was defined as the distance (millimetres) from the bladder neck to the tip of the protruding prostatic tissue, and participants were categorized into Grade I (<5 millimetres), Grade II (5-10 millimetres), or Grade III (>10 millimetres). Ultrasound assessment was performed at baseline and during follow-up per protocol.

Participants received an alpha-adrenergic blocker as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

Participants received a 5-alpha reductase inhibitor as part of standard medical therapy for benign prostatic hyperplasia-related lower urinary tract symptoms. The specific agent, dose, dosing frequency, and duration were prescribed by the treating urologist and recorded throughout follow-up.

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 International Prostate Symptom Score
時間枠:Baseline and 6 months

The International Prostate Symptom Score was used to quantify lower urinary tract symptom severity. The outcome was the change in total score between baseline (pre-treatment) and the 6-month follow-up visit. The International Prostate Symptom Score (IPSS) is a seven-item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe symptoms. The outcome was the change in total IPSS from baseline to the 6-month follow-up visit.

Baseline and 6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in quality of life score
時間枠:Baseline and 6 months

Change in the quality of life index associated with the Intenational Prostate Symptom Score between baseline and 6 months. The International Prostate Symptom Score quality-of-life (IPSS-QoL) question is a single item scored from 0 to 6, where 0 indicates the best quality of life and 6 indicates the worst quality of life related to urinary symptoms. Higher scores indicate worse quality of life. The outcome was the change in IPSS-QoL score from baseline to the 6-month follow-up visit.

Baseline and 6 months
Change in maximum urinary flow rate
時間枠:Baseline and 6 months

Change in maximum urinary flow rate measured by uroflowmetry between baseline and 6 months.

Baseline and 6 months
Change in post-void residual urine volume
時間枠:Baseline and 6 months

Change in post-void residual urine volume measured by transabdominal ultrasonography between baseline and 6 months.

Baseline and 6 months
Change in detrusor wall thickness
時間枠:Baseline and 6 months

Change in detrusor wall thickness measured by transabdominal ultrasonography between baseline and 6 months.

Baseline and 6 months
Need for escalation of management during follow-up
時間枠:Up to 6 months

Proportion of participants who required escalation of management during follow-up (for example, change or intensification of medical therapy or referral for surgical management) due to persistent symptoms or poor objective improvement.

Up to 6 months

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

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)

2025年12月30日

一次修了 (実際)

2026年8月30日

研究の完了 (実際)

2026年8月30日

試験登録日

最初に提出

2025年12月15日

QC基準を満たした最初の提出物

2025年12月15日

最初の投稿 (実際)

2025年12月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月27日

最終確認日

2026年9月1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?

はい

IPD プランの説明

De-identified individual participant data collected during the study will be shared, including baseline and follow-up measurements (International Prostate Symptom Score and quality of life index, uroflowmetry parameters, transabdominal ultrasound parameters including intravesical prostatic protrusion, prostate volume, post-void residual urine, and detrusor wall thickness), along with a data dictionary. Direct identifiers will be removed and data will be coded prior to sharing.

IPD 共有時間枠

De-identified data will be available beginning 6 months after study completion and will remain available for 5 years.

IPD 共有アクセス基準

Data will be shared with qualified researchers upon reasonable request and after review and approval by the study investigators and the institutional administration. Requesters must submit a proposal outlining objectives and planned analyses and must sign a data use agreement that prohibits re-identification and limits use to the approved purpose.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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いいえ

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