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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Qing Yuan
  Beijing, China Recruiting

Study contacts

• Principal investigator: Qing Yuan — Chinese PLA General Hospital
• Study coordinator: Qing Yuan, MD
• Email: rentangl@163.com
• Phone: 19917508192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.