Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia

Medtecx

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Water Vapor Thermal Ablation; Device: Cystoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06725212

PVAS14002P

Details and patient eligibility

About

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. The primary effectiveness endpoint will be changes (treatment group vs control group) from baseline in International Prostate Symptom Score (IPSS) 3 months after medical device intervention.

Enrollment: 126 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

Subjects with BPH with LUTS will be randomized into the treatment group to receive the Water Vapor Thermal treatment via cystoscope.

Treatment:

Device: Water Vapor Thermal Ablation

Sham control group

Sham Comparator group

Description:

Subjects with BPH with LUTS will be randomized into the control group to receive a cystoscopy as the sham treatment. Crossover treatment: 3 months after the sham treatment, qualified subjects in the control group can choose to receive the crossover Water Vapor Thermal treatment via cystoscope.

Treatment:

Device: Cystoscopy

Device: Water Vapor Thermal Ablation