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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT06725212
• Lead Sponsor: Medtecx Co Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-07
• Study First Posted: 2024-12-10
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
IPSS (International Prostate Symptom Score)	• 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.

Secondary Outcome Measures

Name	Time	Method
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	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).
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	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.
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	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.
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	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.
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	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.
BPHII (Benign Prostatic Hyperplasia Impact Index)	• 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.
IIEF-5 (International Index of Erectile Function-5)	• 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.
MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function)	• 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.

Trial Locations

Locations (10)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 HeFei, Anhui, China

Beijing Luhe Hospital Affiliated to Capital Medical University; 🇨🇳 BeiJing, Beijing, China

BeiJing Tsinghua Changgung Hospital; 🇨🇳 BeiJing, Beijing, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 WuHan, Hubei, China

The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 NanJing, Jiangsu, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 NanChang, Jiangxi, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Shanghai First People's Hospital; 🇨🇳 ShangHai, Shanghai, China

The Second Hospital of Tianjin Medical University; 🇨🇳 TianJin, Tianjin, China