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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: steep pulse therapy system; Drug: Tamsulosin Hydrochloride

• Registration Number: NCT06867315
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

The goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (BPH) and to evaluate its safety profile in treating BPH. The main questions it aims to answer are:

1. whether steep pulse ablation can effectively manage BPH symptoms and to investigate any potential safety concerns associated with its use in treating BPH.

2. If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH.

Participants will be asked to do:

1. Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation.

2. Participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-29
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-05-29
• Study Completion: 2026-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
steep pulse therapy system	steep pulse therapy system	-
Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
The change in maximum urinary flow rate	3 months	compare the maximum urinary flow rate of the patients post treatment to the baseline level of the patients

Secondary Outcome Measures

Name	Time	Method
changes in the international prostate symptoms score(IPSS) before and after treatment	screening, 30 days and 3 months	compare the IPSS of the patients in screening stage, 30 days after treatment and 3 months after treatment

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China