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Efficacy of Rezum® in Reducing Prostate Volume

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06315062
Enrollment
289
Registered
2024-03-18
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Hyperplasia of Prostate

Keywords

Prostate, Urology, IPSS score, clinical efficacy, Rezum

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.

Interventions

None listed

Sponsors

Urología Costa Rica
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prostate volumeat 0, 1, 3 and 6 months.Prostate volume

Secondary

MeasureTime frameDescription
International Prostate Symptome Scoreat 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
Urinary flow rateat 0, 1, 3 and 6 months.Urinary flow rate

Countries

Costa Rica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026