Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257654
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2024-01-26
Brief Title:
One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia
Sponsor:
Hisar Intercontinental Hospital
Organization:
Hisar Intercontinental Hospital
Study Overview
Official Title:
One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia BPH that uses injections of sterile water vapor directly into the prostate for tissue ablation Although Rezūm is currently indicated for use in men with prostate sizes 30 and 80 ml it is unclear how effective Rezūm is for men in urinary retention The investigators sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH
Detailed Description:
The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021 and 2023 were evaluated retrospectively The investigators evaluated procedure details and evaluated pre- and post-Rezūm including International Prostate Symptom Score IPSS IPSS quality of life IPSS-QOL prostate volumes maximum flow Qmax post-void residual urine volume IEEF-5 ejaculation dysfunction The investigators examined variables at 6 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None