An observational study in Benign Hyperplasia of Prostate, sponsored by Urología Costa Rica. Completed at 1 site in Costa Rica. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Urología Costa Rica · Observational
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.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 289 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with Urología Costa Rica as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Records of people who have been urology consultants and treated by Dr. Mario González Salas at the UNIBE Hospital from 2020 to the present.
Exclusion Criteria:
Prostate volume
Prostate volume
Time frame: at 0, 1, 3 and 6 months.
International Prostate Symptome Score
International Prostate Symptome Score, minimun score is 0 with midly simptomatic and 35 is the maximun value meaning severely symptomatic
Time frame: at 0, 1, 3 and 6 months.
Urinary flow rate
Urinary flow rate
Time frame: at 0, 1, 3 and 6 months.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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