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OpenTrials
Completed

NCT Number: NCT06315062

Efficacy of Rezum® in Reducing Prostate Volume

This study aimed to assess the efficacy of Rezum® water vapor therapy in reducing prostate volume in patients aged 40 years or older with Benign Prostate Hyperplasia (BPH) at UNIBE Hospital in Costa Rica. A retrospective analysis will be conducted on 289 patient records, focusing on prostate volume, International Prostate Symptom Score (IPSS), and urinary flow rate. Statistical analyses included two-sample mean comparisons, effect size estimation, and linear regression.

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Key information

Conditions

Benign Hyperplasia of Prostate Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital UNIBE

San José, 11301, Costa Rica

About this study

Abstract:

Aim

To estimate the effect size of the prostate volume reduction after application of water vapor injections (Rezum®) in 40 years or older patients, that have been diagnosed with Benign Prostate Hyperplasia (BPH) and are registered at UNIBE Hospital. This contrast provides a retrospective efficacy of the minimally invasive treatment valid for the local population.

Methods:

A retrospective study will be conducted to review patient records, attended at UNIBE Hospital, in Costa Rica. Prostate volume was established as the main variable to assess BPH reversion. Other variables like the International Prostate Symptome Score (IPSS) and urinary flow rate were also evaluated for each patient.

Two sample mean comparisons of baseline and follow up measures for prostate volume and IPSS will be calculated to estimate a mean difference. Effect size parameters like Cohen's d, Hedges's g and Glass's delta were also estimated and compared based on the standard deviation assessment. A linear regression model will also adjuste to obtain values of the statistical contribution from each of the variables included to evaluate the clinical reversal of a benign prostate hyperplasia diagnosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men who received Rezum therapy
  • Men who have been treated at the UNIBE Hospital in Urology by Dr. González

Exclusion criteria

  • Patients without complete data for the previous variables

Treatment and study plan

Primary outcomes

  1. Prostate volume

    Time frame: at 0, 1, 3 and 6 months.

    Prostate volume

Secondary outcomes

  1. International Prostate Symptome Score

    Time frame: at 0, 1, 3 and 6 months.

    International Prostate Symptome Score, minimun score is 0 with midly simptomatic and 35 is the maximun value meaning severely symptomatic

  2. Urinary flow rate

    Time frame: at 0, 1, 3 and 6 months.

    Urinary flow rate

Sponsors and collaborators

Lead sponsor

Urología Costa Rica

Other

Registry information

Official study title

Efficacy of Rezum® in Reducing Prostate Volume. A Retrospective Study in Patients With Benign Hyperplasia in Costa Rica

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2024
Registry last updated
Mar 18, 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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