Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
MALE
NCT07583706

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

Led by Qing Yuan · Updated on 2026-05-13

5

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Subjects who, in the investigator's opinion, are able to complete the study protocol.
Not Eligible

You will not qualify if you...

  • Subjects unable or unwilling to sign informed consent or comply with follow-up requirements.
  • Subjects 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 is excluded by biopsy.
  • Confirmed or suspected prostate or bladder cancer.
  • Use of antiplatelet drugs within 10 days before surgery or planned use within 5 days after surgery.
  • Use of medications affecting sexual function within 3 months before surgery.
  • Presence of neurogenic bladder or detrusor underactivity.
  • BPH complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qing Yuan

Beijing, China, 100000

Actively Recruiting

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Research Team

Q

Qing Yuan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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