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

NCT06725212 | Recruiting

• 1 other identifier: PVAS14002P
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Water Vapor Thermal Therapy

Outcome Measures

Primary Outcomes (1)

• IPSS (International Prostate Symptom Score)

  The IPSS (International Prostate Symptom Score) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). It's minimum value is 0, and maximum value is 35. Lower scores mean a better outcome.

  • Baseline, pre-intervention • 3 months after the initial intervention

Secondary Outcomes (8)

• The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline

  • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

• Qmax (Peak Urinary Flow Rate)

  • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

• PVR (Post-void Residual)

  • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

• Prostate Volume via MRI (Magnetic Resonance Imaging) measurement

  • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

• QoL (Quality of Life)

  • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

Other Outcomes (1)

• Safety evaluations

  • 6 months after the initial intervention

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Device: Water Vapor Thermal Ablation

Sham control group

SHAM COMPARATOR

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.

Device: Water Vapor Thermal Ablation; Device: Cystoscopy

Interventions

Water Vapor Thermal Ablation DEVICE

The water vapor thermal ablation system injects thermal energy in the form of water vapor into the hyperplastic prostate tissue in controlled doses. The injected water vapor quickly disperses through the gaps between tissue cells. When water vapor comes into contact with tissue, it cools and condenses immediately. The stored heat energy is released, denaturing the cell membrane, causing cell death and eventually being absorbed or shed by the body and excreted through urination, thus improving the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).

Also known as: Water Vapor Ablation

Sham control group; Treatment group

Cystoscopy DEVICE

Cystoscopy is a procedure that allows the doctor to examine the lining of patient's bladder and the tube that carries urine out of the body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into the bladder.

Sham control group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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).
• Voluntarily participate in the clinical trial and sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtecx Co Ltd.: lead

Study Sites (10)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 101100, China

RECRUITING

BeiJing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, 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, 430030, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210003, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330038, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Xu Zhang, MD

  PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jim Zhang, MD

CONTACT

jim.zhang@medtecx.com; jim.zhang@medtecx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: March 26, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

CN (10)