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Tests treatment safety and results for Benign Prostatic Hyperplasia
Official title The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT06867315
What this study is testing
What is Tamsulosin Hydrochloride?
Tamsulosin Hydrochloride is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for benign prostatic hyperplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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.
- people are willing to participate and have signed the informed consent form.
You likely can't join if
- 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.
See the full eligibility 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.
- people are willing to participate and have signed the informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.