Clinical trial NCT06315062: Efficacy of Rezum® in Reducing Prostate Volume
Official title: Efficacy of Rezum® in Reducing Prostate Volume. A Retrospective Study in Patients With Benign Hyperplasia in Costa Rica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Hyperplasia of Prostate
Keywords: Prostate
Urology
IPSS score
clinical efficacy
Rezum
Lead sponsor: Urología Costa Rica
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 289
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostate volume
timeFrame: at 0, 1, 3 and 6 months.
Secondary outcomes:
measure: International Prostate Symptome Score
timeFrame: at 0, 1, 3 and 6 months.
measure: Urinary flow rate
timeFrame: at 0, 1, 3 and 6 months.
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Hospital UNIBE
Study officials:
affiliation: Hospital UNIBE
name: Mario González Salas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Costa Rica
name: Milena Castro Mora, PhD.
role: STUDY_DIRECTOR
References: