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New treatment option for Benign Prostatic Hyperplasia (BPH)
Official title Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
ClinicalTrials.gov ID: NCT06817733
What this study is testing
- What it's testing
- Objective of the Clinical Trial The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are: Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 85, men only
You may be able to join if
- Age 45-85 years;
- International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality...
- Poor response to pharmacological treatment or refusal of pharmacological treatment;
- Prostate volume 30-80 mL;
- Maximum urinary flow rate (Qmax) \< 15 mL/s;
You likely can't join if
- Prostate volume \ 80 mL;
- Severe urinary tract infection;
- Preoperative definitive diagnosis of prostate cancer;
- Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
- Patients with prostatitis;
- History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
See the full eligibility criteria
- Age 45-85 years;
- International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;
- Poor response to pharmacological treatment or refusal of pharmacological treatment;
- Prostate volume 30-80 mL;
- Maximum urinary flow rate (Qmax) \< 15 mL/s;
- Post-void residual urine volume (PVR) \< 300 mL;
- Willingness to provide informed consent and participate in postoperative follow-up.
- Prostate volume \ 80 mL;
- Severe urinary tract infection;
- Preoperative definitive diagnosis of prostate cancer;
- Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
- Patients with prostatitis;
- History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
- Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.