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

NCT07583706 | Recruiting

• 1 other identifier: S2025-982-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

BPH (Benign Prostatic Hyperplasia)

Keywords

Benign Prostatic Hyperplasia; LUTS

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score from baseline to 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

Secondary Outcomes (2)

• Change in maximum urinary flow rate from baseline to 3 months after treatment

  Baseline and 3 months after treatment

• Incidence of treatment-related adverse events

  From treatment to 3 months after treatment

Other Outcomes (1)

• Change in quality of life score from baseline to 3 months after treatment

  Baseline and 3 months after treatment

Study Arms (1)

TRUS-Guided Prostatic Dilation Group

EXPERIMENTAL

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.

Device: Prostate Dilation Catheter

Interventions

Prostate Dilation Catheter DEVICE

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.

Also known as: TRUS-guided ultra-minimally invasive prostatic dilation

TRUS-Guided Prostatic Dilation Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qing Yuan: lead

Study Sites (1)

Qing Yuan

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Qing Yuan

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Yuan, MD

CONTACT

19917508192; rentangl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm interventional study. Participants, care providers, investigators, and outcome assessors will not be masked because all enrolled participants will receive TRUS-guided ultra-minimally invasive prostatic dilation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-center, single-arm, prospective exploratory study. All enrolled participants will receive TRUS-guided ultra-minimally invasive prostatic dilation using the investigational prostate dilation catheter. No control group or randomization is included.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)