Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
289 participants
OBSERVATIONAL
2020-01-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Men who have been treated at the UNIBE Hospital in Urology by Dr. González
Exclusion Criteria
40 Years
MALE
No
Sponsors
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Urología Costa Rica
OTHER
Responsible Party
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Mario González
Principal Investigator
Principal Investigators
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Mario González Salas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital UNIBE
Milena Castro Mora, PhD.
Role: STUDY_DIRECTOR
Universidad de Costa Rica
Locations
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Hospital UNIBE
San José, , Costa Rica
Countries
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Other Identifiers
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CEC-UNIBE-07-2023
Identifier Type: -
Identifier Source: org_study_id
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