Ultra-minimally invasive prostate balloon dilation for men with BPH and significant obstruction

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 study tests whether transrectal ultrasound–guided ultra-minimally invasive prostate balloon dilation can reduce urinary symptoms in men aged 40–80 with BPH and significant bladder outlet obstruction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07583706 on ClinicalTrials.gov

What this trial studies

This single-center, single-arm prospective study will enroll five men with symptomatic BPH and confirmed bladder outlet obstruction to receive an ultrasound-guided ultra-minimally invasive prostatic dilation using a dedicated balloon catheter. Eligible participants must have IPSS ≥13, Qmax 5–10 mL/s, prostate volume <30 mL by TRUS, preserved sexual function, and be able to complete follow-up. The procedure is performed under real-time transrectal ultrasound guidance in a minimally invasive setting without general anesthesia. Outcomes including change in IPSS and safety events are measured at 1, 3, and 6 months.

Who should consider this trial

Good fit: Men aged 40–80 with symptomatic BPH, IPSS ≥13, Qmax between 5 and 10 mL/s, prostate volume <30 mL by TRUS, preserved sexual function, and confirmed bladder outlet obstruction are the intended candidates.

Not a fit: Men with larger prostates (>30 mL), suspected or confirmed prostate cancer, active severe urinary infection, neurogenic bladder, bleeding disorders, or those unwilling to follow post-procedure restrictions are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the procedure could offer a short, minimally invasive option to improve urinary symptoms and flow while preserving sexual function and avoiding major surgery.

How similar studies have performed: Minimally invasive prostatic dilation and other MIST procedures have shown modest symptom relief in prior work, but TRUS-guided ultra-minimally invasive balloon dilation is relatively novel and not widely studied.

Eligibility criteria

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.

Where this trial is running

Beijing

• Qing Yuan — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Qing Yuan — Chinese PLA General Hospital
• Study coordinator: Qing Yuan, MD

Conditions BPH; Benign Prostatic Hyperplasia; LUTS