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New treatment option for Benign Prostatic Hyperplasia
Official title Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT06725212
What this study is testing
- What it's testing
- To evaluate the efficacy and safety of the Water Vapor Thermal Therapy system for the treatment of Benign Prostatic Hyperplasia under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related (serious) adverse events.
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 80, men only
You may be able to join if
- Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiring invasive intervention.
- International Prostate Symptom Score (IPSS) ≥13 points.
- Maximum urinary flow rate (Qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml.
- Post-urination residual urine volume (PVR): ≤250 ml.
- Prostate volume measured by MRI: 30\~80 cm³ (including 30 cm³ and 80 cm³).
You likely can't join if
- Malignant lesions of the urinary system, such as prostate cancer or bladder cancer, or other systemic advanced malignant tumors (e.g., gastric...
- Patients with difficulty inserting instruments due to urethral stenosis or bladder neck contracture.
- Severe coagulation disorder.
- Urinary incontinence caused by reduced sphincter function or severe urge urinary incontinence.
- Patients with a history of severe cardiovascular disease, including but not limited to:
- Second/third-degree heart block.
See the full eligibility criteria
- Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiring invasive intervention.
- International Prostate Symptom Score (IPSS) ≥13 points.
- Maximum urinary flow rate (Qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml.
- Post-urination residual urine volume (PVR): ≤250 ml.
- Prostate volume measured by MRI: 30\~80 cm³ (including 30 cm³ and 80 cm³).
- Voluntarily participate in the clinical trial and sign the informed consent form.
- Malignant lesions of the urinary system, such as prostate cancer or bladder cancer, or other systemic advanced malignant tumors (e.g., gastric cancer, liver cancer, lung cancer).
- Patients with difficulty inserting instruments due to urethral stenosis or bladder neck contracture.
- Severe coagulation disorder.
- Urinary incontinence caused by reduced sphincter function or severe urge urinary incontinence.
- Patients with a history of severe cardiovascular disease, including but not limited to:
- Second/third-degree heart block.
- Severe ischemic heart disease.
- Congestive heart failure with New York Heart Association (NYHA) heart function grade ≥ II (mild physical activity limitation; comfortable at rest, but normal activities can cause fatigue, palpitations, or dyspnea).
- Prostate biopsy within 2 months before enrollment.
- Unstable angina, myocardial infarction, transient ischemic attack, or cerebrovascular accident in the past 6 months.
- Patients with previous invasive prostate treatment, such as:
- Radiofrequency (RF) ablation.
- Balloon dilation.
- Microwave therapy.
- Laser treatment.
- Electroreception.
- Prostate urethral stent.
- Suspension procedures.
- History of previous rectal surgery (except hemorrhoidectomy) or history of rectal disease that affects the treatment method or how well it works evaluation in this study.
- Acute urinary and reproductive system infections that are not effectively controlled.
- Neurogenic bladder or neurological diseases that affect bladder function, sphincter function, or detrusor function, as assessed by the researcher.
- Bladder stones.
- people who cannot undergo MRI examination.
- people who are:
- Currently participating in clinical trials.
- Have participated in other drug clinical trials within 3 months.
- Have participated in other medical device clinical trials within 30 days.
- Other situations that the researcher believes are unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China; Nanchang, Jiangxi, China; Xi'an, Shaanxi, China and 2 more location(s). 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.