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

Zhejiang University

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tamsulosin Hydrochloride; Device: steep pulse therapy system

Study type: Interventional

Funder types: Other

Identifiers

NCT06867315

steeppulse-prostate

Details and patient eligibility

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

steep pulse therapy system

Experimental group

Treatment:

Device: steep pulse therapy system

Tamsulosin Hydrochloride

Active Comparator group

Treatment:

Drug: Tamsulosin Hydrochloride