Rezum System Post Market surveillance
Not Applicable
Recruiting
- Conditions
- Patients with bothersome urinary symptoms associated with BPH.
- Registration Number
- JPRN-UMIN000048675
- Lead Sponsor
- Boston Scientific Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Change in BPH symptoms as measured by IPSS change between the baseline to 3 months post-treatment. -Occurrence rate of device-related serious complications defined as: -Device perforation of the rectum or GI tract -Device related formation of fistula between the rectum and urethra; or -De novo severe urinary retention lasting more than 21 consecutive days post-treatment.
- Secondary Outcome Measures
Name Time Method