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NCT06257654 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06257654
Other study ID # 26.01.2024/24-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source Hisar Intercontinental Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• REZUM
The 3rd and 12th month follow-ups of the patients who underwent REZUM operation were evaluated.

Locations
Country Name City State
Turkey Basri Cakiroglu Istanbul
Turkey Hisar Intercontinental Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Hisar Intercontinental Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary q max ml/sn 1 years
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