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NCT Number: NCT06867315

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Tian'an Jiang, PhD

CONTACT

[email protected]

86-18857127666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

steep pulse therapy system

Device
  • Use steep pulse system to ablate the transitional zone of the prostate to treat BPH
  • 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

Drug
  • use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH
  • the brand name is Harnal®
  • the specification is 0.2mg per capsule

Primary outcomes

  1. The change in maximum urinary flow rate

    Time frame: 3 months

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

Secondary outcomes

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

    Time frame: screening, 30 days and 3 months

    compare the IPSS of the patients in screening stage, 30 days after treatment and 3 months after treatment

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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