Rezum System Post Market surveillance

Rezum System Post Market surveillance - Rezum System Post Market surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048675

Enrollment

100

Registered

2022-09-01

Start date

2023-02-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with bothersome urinary symptoms associated with BPH.

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients intended to be treated with Rezum System

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
-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.	—

Countries

Japan

Contacts

Public ContactHiroshi Sakamoto

Boston Scientific Japan K.K. Clinical Affairs

Hiroshi.Sakamoto@bsci.com03-6853-7500

Outcome results