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

December 12, 2024 updated by: Medtecx Co Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • HeFei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • BeiJing, Beijing, China, 101100
        • Recruiting
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • Contact:
      • BeiJing, Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • PLA General Hospital
        • Contact:
    • Hubei
      • WuHan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • NanJing, Jiangsu, China, 210003
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
    • Jiangxi
      • NanChang, Jiangxi, China, 330038
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shanghai
      • ShangHai, Shanghai, China, 200080
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
    • Tianjin
      • TianJin, Tianjin, China, 300211
        • Recruiting
        • The Second Hospital Of Tianjin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
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
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).
Other Names:
  • Water Vapor Ablation
Sham Comparator: Sham control group

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
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).
Other Names:
  • Water Vapor Ablation
Device: Cystoscopy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPSS (International Prostate Symptom Score)
Time Frame: • Baseline, pre-intervention • 3 months after the initial intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
The International Prostate Symptom Score (IPSS) 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).
• 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)
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
In the context of Benign Prostatic Hyperplasia (BPH), "Qmax" refers to the maximum urinary flow rate, which is the fastest rate at which urine can be expelled during a urination test, essentially measuring the peak flow of urine and used as a key indicator to assess the severity of urinary obstruction caused by an enlarged prostate.
• 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)
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
n the context of BPH (Benign Prostatic Hyperplasia), "PVR" stands for "Post-Void Residual," which refers to the amount of urine left in the bladder after a person urinates, essentially measuring how well the bladder is emptying.
• 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
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
MRI, with its advantage of multiplanar imaging and superior soft tissue contrast resolution, can be used in BPH patients to measure the entire prostatic volume.
• 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)
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

A Quality of Life (QoL) questionnaire for patients with benign prostatic hyperplasia (BPH) can include questions about symptoms and possible adverse effects of treatment.

It's minimum value is 0, and maximum value is 6. Lower scores mean a better outcome.
• Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
BPHII (Benign Prostatic Hyperplasia Impact Index)
Time Frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention

A "BPHII score" refers to a score on the "Benign Prostatic Hyperplasia Impact Index" questionnaire, which is used to assess the impact of BPH (benign prostatic hyperplasia) symptoms on a man's quality of life; essentially measuring how much his BPH symptoms interfere with his daily activities and overall well-being.

It's minimum value is 0, and maximum value is 13. Lower scores mean a better outcome.
• Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
IIEF-5 (International Index of Erectile Function-5)
Time Frame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention

The International Index of Erectile Function-5 (IIEF-5) is a shortened, five-item questionnaire used to assess the severity of erectile dysfunction (ED) in men, essentially a simplified version of the longer International Index of Erectile Function (IIEF) which covers a wider range of sexual function domains.

It's minimum value is 1, and maximum value is 25. Higher scores mean a better outcome.
• Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention
MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function)
Time Frame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention

The Male Sexual Health Questionnaire for Ejaculatory Function (MSHQ-EjD) is a shortened version of the Male Sexual Health Questionnaire (MSHQ) specifically designed to assess ejaculatory dysfunction (EjD) in men, focusing on key aspects like the ability to ejaculate, the strength of ejaculation, and the amount of semen produced, allowing clinicians to evaluate potential issues related to ejaculation difficulties.

It's minimum value is 1, and maximum value is 15. Higher scores mean a better outcome.
• Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluations
Time Frame: • 6 months after the initial intervention
  1. (Serious) adverse event rate (%) and number of events;
  2. (Serious) device-related adverse event rate (%) and number of events;
  3. (Serious) device defect rate (%) and number of events.
• 6 months after the initial intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtecx Co Ltd.

Investigators

  • Principal Investigator: Xu Zhang, MD, PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 7, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVAS14002P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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