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A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia (UMPD-BPH)

2026年5月7日 更新者：Qing Yuan

This single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH).

A total of 5 eligible male subjects aged 40 to 80 years with symptomatic BPH, International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) of 5-10 mL/s, prostate volume <30 mL measured by TRUS, and evident bladder outlet obstruction will be enrolled. All subjects will undergo prostatic balloon dilation with the study device under real-time TRUS guidance. Follow-up assessments will be conducted at 1, 3, and 6 months after treatment.

The primary effectiveness endpoint is the change in IPSS from baseline at 1, 3, and 6 months. The primary safety endpoints include bladder neck contracture, retrograde ejaculation, device-related severe urinary retention persisting for more than 14 days after healing, new-onset stress urinary incontinence, device-related bleeding requiring transfusion, and device-related urethral or prostatic capsular rupture requiring surgical intervention.

Secondary endpoints include responder rates based on different thresholds of IPSS improvement (≥30%, ≥40%, and ≥50%), changes in Qmax, and changes in visual analogue scale (VAS) scores. Exploratory endpoints include changes in postvoid residual urine volume (PVR) and sexual function assessed by the International Index of Erectile Function (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).

This exploratory study is intended to provide preliminary clinical evidence supporting the safety and potential clinical benefit of TRUS-guided ultra-minimally invasive prostatic dilation for BPH-related obstruction and to inform future larger-scale clinical studies.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a single-center, single-arm, prospective exploratory clinical study designed to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in patients with benign prostatic hyperplasia (BPH) associated with significant bladder outlet obstruction.

A total of 5 eligible male participants will be enrolled. Eligible subjects are 40 to 80 years of age, have moderate to severe lower urinary tract symptoms, an International Prostate Symptom Score (IPSS) of at least 13, a maximum urinary flow rate (Qmax) between 5 and 10 mL/s, and a prostate volume less than 30 mL as measured by TRUS. All participants must have clinically confirmed BPH with significant bladder outlet obstruction and preserved sexual function. Key exclusion criteria include suspected or confirmed malignancy, severe urinary tract infection, bleeding tendency, neurogenic bladder, and other conditions considered unsuitable for the procedure.

After providing written informed consent, each participant will undergo ultra-minimally invasive prostatic dilation with the study device under real-time TRUS guidance. The procedure is intended to be performed in a minimally invasive setting without the need for general anesthesia. Follow-up evaluations will be conducted at 1, 3, and 6 months after treatment.

Efficacy assessments will focus on changes from baseline in IPSS at 1, 3, and 6 months after the procedure. Safety assessments will include the occurrence of adverse events such as bladder neck contracture, retrograde ejaculation, device-related prolonged urinary retention lasting more than 14 days after healing, stress urinary incontinence, bleeding requiring transfusion, and urethral or prostatic capsular rupture requiring surgical intervention. Secondary outcomes include responder rates based on different thresholds of IPSS improvement, changes in Qmax and visual analogue scale (VAS) scores, and exploratory changes in postvoid residual urine volume (PVR) and sexual function parameters, including the International Index of Erectile Function-5 (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD).

This study is intended to generate preliminary clinical evidence regarding the safety and potential therapeutic benefit of TRUS-guided ultra-minimally invasive prostatic dilation for the treatment of BPH-related bladder outlet obstruction, and to support the design of future larger-scale clinical investigations.

研究の種類

介入

入学 (推定)

5

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

  • 名前：Qing Yuan, MD
  • 電話番号：19917508192
  • メール：rentangl@163.com

研究場所

  • 中国
      • Beijing、中国、100000
        • 募集
        • Qing Yuan
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Qing Yuan

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:

  • Male subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia (BPH) and obvious bladder outlet obstruction.
  • Subjects with normal sexual life and a sexual partner, and with intact sexual function.
  • International Prostate Symptom Score (IPSS) ≥ 13.
  • Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume ≥ 150 mL.
  • Prostate volume measured by transrectal ultrasound (TRUS) < 30 mL. Prostate volume is calculated as length × width × height × 0.52.
  • Subjects who, in the investigator's opinion, are able to complete the study protocol.

Exclusion Criteria:

  • Subjects who are unable or unwilling to sign the informed consent form (ICF) and/or comply with all follow-up requirements.
  • Subjects who are unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment.
  • Prostate-specific antigen (PSA) ≥ 10 ng/mL, unless prostate cancer has been excluded by biopsy.
  • Confirmed or suspected prostate or bladder malignancy.
  • Use of antiplatelet drugs, such as clopidogrel or aspirin, within 10 days before surgery, or planned use within 5 days after surgery.
  • Use of medications within 3 months before surgery that, in the investigator's opinion, may affect sexual function.
  • Presence of neurogenic bladder or detrusor underactivity affecting bladder/sphincter function.
  • Patients with BPH complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.

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：なし
  • 介入モデル：単一グループの割り当て
  • 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
実験的：TRUS-Guided Prostatic Dilation Group
Participants in this arm will receive ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance for the treatment of benign prostatic hyperplasia-associated bladder outlet obstruction.
デバイス：Prostate Dilation Catheter
The intervention consists of ultra-minimally invasive dilation of the prostatic urethra using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance. The treatment is designed to relieve bladder outlet obstruction caused by benign prostatic hyperplasia while preserving urinary and sexual function.
他の名前：
  • TRUS-guided ultra-minimally invasive prostatic dilation

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 from baseline to 3 months after treatment
時間枠：Baseline and 3 months after treatment
The International Prostate Symptom Score, or IPSS, will be used to evaluate lower urinary tract symptoms associated with benign prostatic hyperplasia. The score ranges from 0 to 35, with higher scores indicating more severe symptoms. The change in IPSS from baseline to 3 months after treatment will be assessed.
Baseline and 3 months after treatment

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in maximum urinary flow rate from baseline to 3 months after treatment
時間枠：Baseline and 3 months after treatment
Maximum urinary flow rate, or Qmax, will be measured by uroflowmetry. The change in Qmax from baseline to 3 months after treatment will be assessed. A higher Qmax indicates improved urinary flow.
Baseline and 3 months after treatment
Incidence of treatment-related adverse events
時間枠：From treatment to 3 months after treatment
The incidence, severity, and relationship to the study procedure or device of adverse events will be recorded throughout the study. Adverse events may include hematuria, urinary tract infection, urinary retention, pain, dysuria, urethral injury, or other procedure-related complications.
From treatment to 3 months after treatment

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in quality of life score from baseline to 3 months after treatment
時間枠：Baseline and 3 months after treatment
The quality of life score related to urinary symptoms will be assessed using the quality of life question of the International Prostate Symptom Score. The score ranges from 0 to 6, with higher scores indicating worse quality of life. The change from baseline to 3 months after treatment will be evaluated.
Baseline and 3 months after treatment

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

Qing Yuan

捜査官

  • 主任研究者：Qing Yuan、Chinese PLA General Hospital

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1月1日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月7日

最初の投稿 (実際)

2026年5月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月13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7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

  • S2025-982-01

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 this is a small, single-center exploratory study and the data contain sensitive clinical information, including urological symptoms and sexual function assessments. To protect participant privacy and confidentiality, individual-level data will not be made available. Aggregate study results may be shared after completion of the study.

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

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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