NCT06257654

One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Hisar Intercontinental Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 100 Years
• Healthy volunteers: Accepted

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).

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	REZUM	The 3rd and 12th month follow-ups of the patients who underwent REZUM operation were evaluated.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2024-02-14
• Last updated: 2024-02-15

Locations

2 sites across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study