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

NCT06867315 | Recruiting DMC

• 1 other identifier: steeppulse-prostate
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 2.If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH.
3. 3.Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation.
4. 4.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

Keywords

steep pulse ablation

Outcome Measures

Primary Outcomes (1)

• The change in maximum urinary flow rate

  compare the maximum urinary flow rate of the patients post treatment to the baseline level of the patients

  3 months

Secondary Outcomes (1)

• changes in the international prostate symptoms score(IPSS) before and after treatment

  screening, 30 days and 3 months

Study Arms (2)

steep pulse therapy system

EXPERIMENTAL

Device: steep pulse therapy system

Tamsulosin Hydrochloride

ACTIVE COMPARATOR

Drug: Tamsulosin Hydrochloride

Interventions

steep pulse therapy system 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

steep pulse therapy system

Tamsulosin Hydrochloride 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

Tamsulosin Hydrochloride

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
• international prostate symptom score(IPSS)\>=12.
• Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml.
• Age ≥ 50 years old.
• Subjects are willing to participate and have signed the informed consent form.

You may not qualify if:

• Patients with acute or severe urinary tract infections.
• Patients clinically diagnosed with prostate cancer.
• Patients with neurogenic bladder or bladder dysfunction due to other factors.
• Patients with urethral stricture.
• Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
• Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
• Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
• Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
• Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
• Patients deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: collaborator
• First People's Hospital of Hangzhou: collaborator
• Fujian Provincial Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: May 29, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

CN (1)