Efficacy of Rezum® in Reducing Prostate Volume
- Conditions
- Benign Hyperplasia of Prostate
- Registration Number
- NCT06315062
- Lead Sponsor
- Urología Costa Rica
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 289
- Men who received Rezum therapy
- Men who have been treated at the UNIBE Hospital in Urology by Dr. González
- Patients without complete data for the previous variables
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prostate volume at 0, 1, 3 and 6 months. Prostate volume
- Secondary Outcome Measures
Name Time Method Urinary flow rate at 0, 1, 3 and 6 months. Urinary flow rate
International Prostate Symptome Score 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
Trial Locations
- Locations (1)
Hospital UNIBE
🇨🇷San José, Costa Rica