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

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Device: REZUM

• Registration Number: NCT06257654
• Lead Sponsor: Hisar Intercontinental Hospital

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-01-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

-Benign prostatic hyperplasia

Exclusion Criteria

• Prostate cancer
• Parkinson's disease,
• Neurogenic bladder
• Overactive bladder
• Bladder calculus,
• Bladder Tumor
• Urinary infection
• Alzheimer's disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
singel	REZUM	-

Primary Outcome Measures

Name	Time	Method
q max	1 years	ml/sn
quality of life index	1 years	Scoring from 1-4, An increase in the quality of life means an increase in the score, or a decrease in the quality of life means a decrease in the score.
International Prostate Symptom Score,	1 years	Scoring from 1-35, An increase in symptoms means an increase in the score, or a decrease in symptoms means a low score.

Trial Locations

Locations (2)

Basri Cakiroglu; 🇹🇷 Istanbul, Turkey

Hisar Intercontinental Hospital; 🇹🇷 Istanbul, Turkey