To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: Rezūm System

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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• China
  • Hainan
    • Boao, Hainan, China, 571437
      • Boao Yiling Life Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• This is a retrospective study without any formal exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During Rezūm procedure
Length of Catheterization	Length of Catheterization is the date from date of catheter implantation to date of catheter removal	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	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.	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.	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	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	From baseline to the last follow-up date, anywhere between month 3 - month 6

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Ming Liu, Dr, Boao Yiling Life Care Center

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: U0719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes