The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called steep pulse ablation for men with benign prostatic hyperplasia (BPH), a condition that causes an enlarged prostate and can lead to bothersome urinary symptoms. The study aims to find out if this new therapy is effective in relieving BPH symptoms and whether it is safe to use. It will also compare how well steep pulse ablation works compared to a commonly prescribed medication called Tamsulosin Hydrochloride.

To participate, men aged 50 and older who have been diagnosed with BPH and have certain urinary flow rates and symptom scores may be eligible. Participants will either receive the medication or undergo the steep pulse ablation procedure. They will have follow-up visits one month and three months after starting treatment to check on their progress and any side effects. If you or a loved one is facing challenges due to BPH, this trial could be an opportunity to explore a new treatment option.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
• • 2. international prostate symptom score(IPSS)\>=12.
• • 3. Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml.
• • 4. Age ≥ 50 years old.
• • 5. Subjects are willing to participate and have signed the informed consent form.
• Exclusion Criteria:
• • 1. Patients with acute or severe urinary tract infections.
• • 2. Patients clinically diagnosed with prostate cancer.
• • 3. Patients with neurogenic bladder or bladder dysfunction due to other factors.
• • 4. Patients with urethral stricture.
• • 5. Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
• • 6. Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
• • 7. Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
• • 8. Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
• • 9. Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
• • 10. Patients deemed unsuitable for participation in this clinical trial by the investigator.