Efficacy of Rezum® in Reducing Prostate Volume

March 13, 2024 updated by: Mario González, Urología Costa Rica

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
      • San José, Costa Rica, 11301
        • Hospital UNIBE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Records of people who have been urology consultants and treated by Dr. Mario González Salas at the UNIBE Hospital from 2020 to the present.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate volume
Time Frame: at 0, 1, 3 and 6 months.
Prostate volume
at 0, 1, 3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 0, 1, 3 and 6 months.
Urinary flow rate
Time Frame: at 0, 1, 3 and 6 months.
Urinary flow rate
at 0, 1, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urología Costa Rica

Investigators

  • Principal Investigator: Mario González Salas, Dr., Hospital UNIBE
  • Study Director: Milena Castro Mora, PhD., Universidad de Costa Rica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC-UNIBE-07-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Hyperplasia of Prostate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe