Benign Prostatic HyperplasiaNCT06725212
Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia
A study testing Water Vapor Thermal Ablation and Cystoscopy in people with Benign Prostatic Hyperplasia, run by Medtecx Co Ltd. at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Water Vapor Thermal Ablation and Cystoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 10 sitesChina
- Study dates
- 26 Mar 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101100
Jiaming Liu, lhgcp@bjtzh.gov.cn, lhgcp@bjtzh.gov.cn
- Recruiting
BeiJing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Xuan Liu, GCP@btch.edu.cn, GCP@btch.edu.cn
- Recruiting
PLA General Hospital
Beijing, Beijing Municipality
Fenglin Wang, gcp_wjzyy@tom.com, gcp_wjzyy@tom.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Xianai Wang, 1587621523@qq.com, 1587621523@qq.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038
Luyi Yu, ncuyfygcp2018@163.com, ncuyfygcp2018@163.com
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210003
Huijie Zhang, aa58509670@163.com, aa58509670@163.com
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Wan Zhu, shiyigcp@126.com, shiyigcp@126.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Shen Zhang, zsshen26@163.com, zsshen26@163.com
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Chang Shu, tongjigcp@163.com, tongjigcp@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yu Liu, xayyyljd@163.com, xayyyljd@163.com
About this study
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
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
- Being tested
- Water Vapor Thermal Ablation, Cystoscopy
- Keywords
- Water Vapor Thermal Therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Vapor Thermal AblationDevice
Also called Water Vapor 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).
CystoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Water Vapor Thermal Ablation; Device: Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • 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
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).
Measured: • 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)
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.
Measured: • 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)
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.
Measured: • 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
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.
Measured: • 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)
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.
Measured: • 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)
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.
Measured: • 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)
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.
Measured: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention
MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function)
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.
Measured: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtecx Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu Zhang, MD, Principal investigator, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725212
- Sponsor's protocol ID
- PVAS14002P
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06725212
- Acronym / sponsor ID
- PVAS14002P
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Water Vapor Thermal Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Medtecx Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Water Vapor Thermal AblationSubjects with BPH with LUTS will be randomized into the treatment group to receive the Water Vapor Thermal treatment via cystoscope. |
| Sham control group | Sham comparator | Device: Water Vapor Thermal Ablation, Device: CystoscopySubjects 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Vapor Thermal AblationAlso: Water Vapor AblationThe 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). | Device | Sham control group, Treatment group |
| CystoscopyCystoscopy 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. | Device | Sham control group |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xu Zhang, MD principal investigator
PLA General Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Vapor Thermal Ablation and Cystoscopy in people with Benign Prostatic Hyperplasia, run by Medtecx Co Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jim Zhang, MD (jim.zhang@medtecx.com, jim.zhang@medtecx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS (International Prostate Symptom Score) (time frame: • Baseline, pre-intervention • 3 months after the initial intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.