Clinical trial NCT06725212: Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Water Vapor Thermal Therapy
Lead sponsor: Medtecx Co Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 126
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: IPSS (International Prostate Symptom Score)
timeFrame: • Baseline, pre-intervention • 3 months after the initial intervention
Secondary outcomes:
measure: The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: Qmax (Peak Urinary Flow Rate)
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: PVR (Post-void Residual)
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: Prostate Volume via MRI (Magnetic Resonance Imaging) measurement
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: QoL (Quality of Life)
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: BPHII (Benign Prostatic Hyperplasia Impact Index)
timeFrame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: IIEF-5 (International Index of Erectile Function-5)
timeFrame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention
measure: MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function)
timeFrame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention
Other outcomes:
measure: Safety evaluations
timeFrame: • 6 months after the initial intervention
Locations:
city: HeFei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: BeiJing
country: China
facility: Beijing Luhe Hospital Affiliated to Capital Medical University
state: Beijing
city: BeiJing
country: China
facility: BeiJing Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
city: WuHan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: NanJing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: NanChang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: ShangHai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: TianJin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
Study officials:
affiliation: PLA General Hospital
name: Xu Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: