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

NCT ID: NCT06867315

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2026-05-29

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

steep pulse therapy system

Group Type: EXPERIMENTAL

steep pulse therapy system

Intervention Type: DEVICE

1. Use steep pulse system to ablate the transitional zone of the prostate to treat BPH

2. The steep pulse generator employs irreversible electroporation technology, which involves inserting electrodes into the tumor and delivering high-voltage electrical pulses to create nanoscale permanent pores on the lipid bilayer of tumor cell membranes. This disrupts the intracellular balance and induces cell apoptosis

Tamsulosin Hydrochloride

Group Type: ACTIVE_COMPARATOR

Tamsulosin Hydrochloride

Intervention Type: DRUG

1. use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH

2. the brand name is Harnal®

3. the specification is 0.2mg per capsule

Interventions

steep pulse therapy system

1. Use steep pulse system to ablate the transitional zone of the prostate to treat BPH

2. The steep pulse generator employs irreversible electroporation technology, which involves inserting electrodes into the tumor and delivering high-voltage electrical pulses to create nanoscale permanent pores on the lipid bilayer of tumor cell membranes. This disrupts the intracellular balance and induces cell apoptosis

Intervention Type: DEVICE

Tamsulosin Hydrochloride

1. use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH

2. the brand name is Harnal®

3. the specification is 0.2mg per capsule

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of University of Science and Technology of China

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Tian'an Jiang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tian'an Jiang, PhD

Role: primary

tiananjiang@126.com

86-18857127666

Other Identifiers

steeppulse-prostate

Identifier Type: -

Identifier Source: org_study_id