Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315062
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-02-22
Brief Title:
Efficacy of Rezum in Reducing Prostate Volume
Sponsor:
Urología Costa Rica
Organization:
Urología Costa Rica
Study Overview
Official Title:
Efficacy of Rezum in Reducing Prostate Volume A Retrospective Study in Patients With Benign Hyperplasia in Costa Rica
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Cohens d Hedgess g and Glasss 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
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 Cohens d Hedgess g and Glasss 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None