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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06257654

Enrollment

Registered

2024-02-14

Start date

2021-01-01

Completion date

2023-12-31

Last updated

2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

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).

Interventions

DEVICEREZUM

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

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
q max	1 years	ml/sn

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026