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OpenTrials
Completed

NCT Number: NCT06257654

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

40 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Basri Cakiroglu, Istanbul, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rezum

Device

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

Primary outcomes

  1. International Prostate Symptom Score,

    Time frame: 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.

  2. quality of life index

    Time frame: 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.

  3. q max

    Time frame: 1 years

    ml/sn

Sponsors and collaborators

Lead sponsor

Hisar Intercontinental Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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