Benign Prostatic Hyperplasia
Conditions
Keywords
steep pulse ablation
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. 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.
Interventions
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
1. use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH 2. the brand name is Harnal® 3. the specification is 0.2mg per capsule
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
The First Affiliated Hospital of University of Science and Technology of China
First People's Hospital of Hangzhou
Fujian Provincial Hospital
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in maximum urinary flow rate | 3 months | compare the maximum urinary flow rate of the patients post treatment to the baseline level of the patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the international prostate symptoms score(IPSS) before and after treatment | screening, 30 days and 3 months | compare the IPSS of the patients in screening stage, 30 days after treatment and 3 months after treatment |
Countries
China
Outcome results
None listed