Evaluating a new therapy for benign prostatic hyperplasia

Prospective, Multicenter, Randomized, Controlled, and Superiority Clinical Trial on the Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

This study tests a new treatment called steep pulse therapy for men with benign prostatic hyperplasia to see if it works better than the usual medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: First Affiliated Hospital of Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06867315 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the steep pulse therapy system for treating benign prostatic hyperplasia (BPH). Participants will either receive Tamsulosin Hydrochloride or undergo the steep pulse ablation procedure. The study will evaluate symptom management and safety concerns associated with steep pulse ablation compared to the standard medication. Follow-up assessments will occur at one and three months post-treatment to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are men aged 50 and older diagnosed with BPH and experiencing moderate symptoms.

Not a fit: Patients with prostate cancer or those who have had previous prostate surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new effective treatment option for patients suffering from BPH.

How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in using ablation techniques for BPH treatment.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Conditions: Benign Prostatic Hyperplasia, steep pulse ablation