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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2026-05-29
Participants
Target number of participants: 10
Treatments
Experimental: steep pulse therapy system
Active_comparator: Tamsulosin Hydrochloride
Related Therapeutic Areas
Sponsors
Collaborators: Fujian Provincial Hospital, The First Affiliated Hospital of University of Science and Technology of China, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, First People's Hospital of Hangzhou
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov