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)

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.

Study Overview

• Status: Recruiting
• Conditions: BPH (Benign Prostatic Hyperplasia)
• Intervention / Treatment: Device: Prostate Dilation Catheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qing Yuan, MD; Phone Number: 19917508192; Email: rentangl@163.com

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Qing Yuan
    • Contact: Qing Yuan; Phone Number: 19917508192; Email: rentangl@163.com
    • Contact: Rentang Li; Phone Number: 19917508192; Email: rentangl@163.com
    • Principal Investigator: Qing Yuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; Other Names: TRUS-guided ultra-minimally invasive prostatic dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximum urinary flow rate from baseline to 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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life score from baseline to 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

Collaborators and Investigators

• Sponsor: Qing Yuan
• Investigators: Principal Investigator: Qing Yuan, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; LUTS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: S2025-982-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No