Treatment of enlarged prostate using water vapor therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of the Water Vapor Thermal Therapy system for treating Benign Prostatic Hyperplasia (BPH). It aims to compare the treatment group with a control group by measuring changes in the International Prostate Symptom Score (IPSS) three months after the intervention. The study focuses on ensuring participant safety while scientifically assessing the device's effectiveness. Participants will undergo water vapor thermal ablation and cystoscopy as part of the treatment process.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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 efficacy 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.
* Subjects who cannot undergo MRI examination.
* Subjects 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.

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Beijing Luhe Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• BeiJing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Recruiting
• PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Xu Zhang, MD — PLA General Hospital
• Study coordinator: Jim Zhang, MD
• Email: jim.zhang@medtecx.com
• Phone: jim.zhang@medtecx.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sonablate HIFU Registry for Prostate Cancer and BPH

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• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

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• MRI-DTI look at the urethral sphincter ring and prostate base shape

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• Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

  This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.

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• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

  This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07650968

• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

  This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.