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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)

7 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

5

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Beijing, Cina, 100000
        • Reclutamento
        • Qing Yuan
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Qing Yuan

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altri nomi:
  • TRUS-guided ultra-minimally invasive prostatic dilation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in International Prostate Symptom Score from baseline to 3 months after treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in maximum urinary flow rate from baseline to 3 months after treatment
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in quality of life score from baseline to 3 months after treatment
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Qing Yuan

Investigatori

  • Investigatore principale: Qing Yuan, Chinese PLA General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S2025-982-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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