Clinical trial NCT04823221: To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-30
Enrollment: 22
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
timeFrame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure
measure: Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
timeFrame: from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
Secondary outcomes:
measure: Rezūm Procedure Time
timeFrame: During Rezūm procedure
measure: Length of Catheterization
timeFrame: 1 month post Rezum procedure
measure: The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.
timeFrame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
measure: Post Void Residual Urine Volume (PVR）
timeFrame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.
measure: Quality of Life (Qol)
timeFrame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
measure: Ejective Function (MSHQ-EjD)
timeFrame: from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure
measure: The Change of International Index of Erectile Function(IIEF) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6
timeFrame: From baseline to the last follow-up date, anywhere between month 3 - month 6
Other outcomes:
Locations:
city: Boao
country: China
facility: Boao Yiling Life Care Center
state: Hainan
Study officials:
affiliation: Boao Yiling Life Care Center
name: Ming Liu, Dr
role: PRINCIPAL_INVESTIGATOR
References: