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

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.

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.