Treatment of enlarged prostate using water vapor therapy

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Water Vapor Thermal Ablation System for the Treatment of Benign Prostatic Hyperplasia

This study is testing if a new water vapor treatment can help men with an enlarged prostate feel better by reducing their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 45 Years to 80 Years
• Sex: Male
• Sponsor: Medtecx Co Ltd. (Industry-sponsored)
• Locations: 10 sites (Hefei, Anhui and 9 other locations)
• Trial ID: NCT06725212 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men aged 45-80 with moderate to severe BPH symptoms requiring invasive intervention.

Not a fit: Patients with prostate cancer or other advanced malignancies, severe urinary incontinence, or significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a minimally invasive treatment option for men suffering from BPH, improving their quality of life.

How similar studies have performed: Other studies have shown promise with similar thermal therapies for BPH, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 9 other locations

• 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)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• Shanghai First People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xu Zhang, MD — PLA General Hospital
• Study coordinator: Jim Zhang, MD

Conditions Benign Prostatic Hyperplasia; Water Vapor Thermal Therapy