Benign Prostatic Hyperplasia (BPH)NCT04823221
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
An observational study of Benign Prostatic Hyperplasia (BPH), run by Boston Scientific Corporation at 1 site in China.
Trial summary
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Rezūm System
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Up to 30 subjects who were diagnosed as BPH and treated with Rezūm system will be collected to get 22 treated subjects with valid data.
Who may be able to join
- The subjects will provide written informed consent form and agree to data collection.
- The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
Who cannot join
- This is a retrospective study without any formal exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
Read the detailed description
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Rezūm System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezūm SystemDevice
The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Rezūm system | The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. Receives: Device: Rezūm System |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing.
7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms.
IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus
Measured: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure
Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
Composite device related serious complications for this endpoint are defined as:
- Device perforation of the rectum or GI tract;
- Device related formation of fistula between the rectum and urethra;
- De novo severe urinary retention lasting more than 21 consecutive days post treatment.
Measured: from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Secondary outcomes (7)
Rezūm Procedure Time
Rezūm procedure time is refers to the urethral entry of the catheter by Rezūm and exit after the ablation of the catheter by Rezūm
Measured: During Rezūm procedure
Length of Catheterization
Length of Catheterization is the date from date of catheter implantation to date of catheter removal
Measured: 1 month post Rezum procedure
The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
The change of Peak Flow Rate (Qmax) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. Which are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline
Measured: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Post Void Residual Urine Volume (PVR）
The change of Post Void Residual Urine Volume (PVR）from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure. The change are the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6 minus.
Measured: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Quality of Life (Qol)
The change of Quality of Life from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. There is only 1 question about Quality of life due to urinary symptoms which is 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' This question have 0-6 scores according to patient's satisfaction about Quality of Life, the higher score mean patient have poor satisfaction.
The change was the baseline value minus the value at the last follow-up date, anywhere between month 3 - month 6.
Measured: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
Ejective Function (MSHQ-EjD)
The change of Ejective function-Male Sexual Health Questionnaire Short Form- Ejaculation dysfunction（MSHQ-EjD ) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Ejective function (MSHQ-EjD) is a questionnaire used to assess the ejective function. There are 4 questions relating to Ejaculation dysfunction which need patients to answer.
3 questions about patients' ejective function assessing include completion of ejaculation, Strength of ejaculation and Volume of semen when ejaculation. Every question have 0-5 scores according to assessing the ejective function, the lower score mean patient have more severe the ejective function.
MSHQ-EjD total score: the minimum score is 0 and maximum score are 15. The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline
Measured: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6
The change of the International Index of Erectile Function(IIEF) from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure. Erectile Function(IIEF) is a questionnaire used to assess the Sexual Health Inventory of men. There are 5 questions relating to Erectile Function which need patients to answer. Every question have 0-5 scores, the lower score mean patient have more severe the Erectile Function.
The IIEF-5 is administered as a screening instrument for the presence \& severity of ED in conjunction with the clinical assessment. The score is the sun of the responses to the five items, so that overall score may range from 0 to 25. A score of 20 or higher indicates a normal degree of erectile functioning. Low scores (10 or less) indicate moderate to severe ED.
The change are the value at the last follow-up date, anywhere between month 3 - month 6 minus value at baseline
Measured: From baseline to the last follow-up date, anywhere between month 3 - month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start10 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ming Liu, Dr, Principal investigator, Boao Yiling Life Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823221
- Sponsor's protocol ID
- U0719
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)
- ClinicalTrials.gov ID
- NCT04823221
- Acronym / sponsor ID
- U0719
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
Detailed description
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezūm system | – | Device: Rezūm SystemThe basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 30 subjects who were diagnosed as BPH and treated with Rezūm system will be collected to get 22 treated subjects with valid data.
Key inclusion criteria (2 listed)
- The subjects will provide written informed consent form and agree to data collection.
- The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
Key exclusion criteria (1 listed)
- This is a retrospective study without any formal exclusion criteria.
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 |
|---|---|---|
| Rezūm SystemThe basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra. | Device | Rezūm system |
Primary outcome
International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
Time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure
International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus
Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
Time frame: from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Composite device related serious complications for this endpoint are defined as: 1. Device perforation of the rectum or GI tract; 2. Device related formation of fistula between the rectum and urethra; 3. De novo severe urinary retention lasting more than 21 consecutive days post treatment.
7 secondary outcomes
Rezūm Procedure Time
Time frame: During Rezūm procedure
Length of Catheterization
Time frame: 1 month post Rezum procedure
The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
Time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Post Void Residual Urine Volume (PVR）
Time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Quality of Life (Qol)
Time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
Ejective Function (MSHQ-EjD)
Time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6
Time frame: From baseline to the last follow-up date, anywhere between month 3 - month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ming Liu, Dr principal investigator
Boao Yiling Life Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by Boston Scientific Corporation at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure. (time frame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure). The study lists 2 primary outcomes in all. 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 2 Mar 2022.