Actively Recruiting
The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-03-10
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with benign prostatic hyperplasia by digital rectal exam, B-mode ultrasound, and urinary flow rate
- International prostate symptom score (IPSS) of 12 or higher
- Maximum urinary flow rate greater than 5 ml/s and less than 15 ml/s with a minimum voided volume of at least 150 ml
- Age 50 years or older
- Willingness to participate and signed informed consent form
You will not qualify if you...
- Acute or severe urinary tract infections
- Clinical diagnosis of prostate cancer
- Neurogenic bladder or bladder dysfunction from other causes
- Urethral stricture
- Previous prostate surgeries including TURP, enucleation, or laser surgery
- Implanted pacemakers or metal replacements in pelvis or hip joints
- Inability to tolerate general anesthesia or surgery due to severe systemic diseases or organ failure
- Use of medications affecting BPH symptoms within 3 months of follow-up in trial group
- Participation in other drug or medical device trials within 3 months before enrollment
- Investigator's assessment deeming the patient unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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