Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new ultra-minimally invasive procedure to widen the prostate using a special dilation catheter guided by real-time transrectal ultrasound (TRUS) in men with significant bladder outlet obstruction caused by benign prostatic hyperplasia (BPH). This small, single-center, single-arm study plans to enroll 5 male participants aged 40 to 80 years who have moderate to severe urinary symptoms and confirmed prostate obstruction. The study aims to provide preliminary clinical evidence to support future larger studies. Participants will receive the prostate dilation treatment using a dedicated catheter under TRUS guidance without general anesthesia. The procedure is designed to relieve obstruction while preserving urinary and sexual function. After the treatment, participants will be followed up at 1, 3, and 6 months to assess symptom changes and safety. This includes monitoring for complications such as bladder neck contracture, retrograde ejaculation, prolonged urinary retention, stress urinary incontinence, bleeding, and tissue rupture that may require surgery. During the study, researchers will assess symptom improvement using the International Prostate Symptom Score (IPSS), urinary flow rate (Qmax), and pain levels using a visual analogue scale (VAS). They will also explore changes in residual urine volume after urination and sexual function using established questionnaires. Safety will be closely monitored throughout the follow-up period. The total study duration for each participant will be at least 6 months post-treatment.
CONDITIONS
Brief 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
Eligibility Criteria
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) 2 13.
- Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume 2 150 mL.
- Prostate volume measured by transrectal ultrasound (TRUS) less than 30 mL.
- Subjects who are able to complete the study protocol according to the investigator's opinion.
You will not qualify if you...
- Unable or unwilling to sign the informed consent form (ICF) or comply with follow-up requirements.
- Unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment.
- Prostate-specific antigen (PSA) 2 10 ng/mL unless prostate cancer is excluded by biopsy.
- Confirmed or suspected prostate or bladder malignancy.
- Use of antiplatelet drugs within 10 days before surgery or planned use within 5 days after surgery.
- Use of medications within 3 months before surgery that may affect sexual function.
- Presence of neurogenic bladder or detrusor underactivity affecting bladder or sphincter function.
- BPH complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Single day procedure
Participants undergo ultra-minimally invasive prostatic dilation using a dedicated prostate dilation catheter under real-time transrectal ultrasound guidance to relieve bladder outlet obstruction caused by benign prostatic hyperplasia.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for safety and effectiveness of the treatment, with assessments at multiple time points after the procedure.
3 visits at 1, 3, and 6 months after treatment (in-person)
Trial Site Locations
Total: 1 location
1
Qing Yuan
Beijing, China, 100000
Actively Recruiting
Research Team
Q
Qing Yuan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here