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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Device: REZUM

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34768
    • Hisar Intercontinental Hospital
  • Istanbul, Turkey, 34768
    • Basri Cakiroglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

male patients with prostate symptoms

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
singel	Device: REZUM; The 3rd and 12th month follow-ups of the patients who underwent REZUM operation were evaluated.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hisar Intercontinental Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 26.01.2024/24-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes