NCT06315062

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

February 22, 2024

Last Update Submit

March 13, 2024

Conditions

Benign Hyperplasia of Prostate

Keywords

ProstateUrologyIPSS scoreclinical efficacyRezum

Outcome Measures

Primary Outcomes (1)

  • Prostate volume

    Prostate volume

    at 0, 1, 3 and 6 months.

Secondary Outcomes (2)

  • International Prostate Symptome Score

    at 0, 1, 3 and 6 months.

  • Urinary flow rate

    at 0, 1, 3 and 6 months.

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients without complete data for the previous variables

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital UNIBE

San José, 11301, Costa Rica

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mario González Salas, Dr.

    Hospital UNIBE

    PRINCIPAL INVESTIGATOR

  • Milena Castro Mora, PhD.

    Universidad de Costa Rica

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 18, 2024

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

CO(1)