Efficacy of Rezum(R) in reducing prostate volume. A retrospective study in patients with benign hyperplasia in Costa Rica.

Abstract

Resumen Aim To contrast the eficacy in reduction of the prostatic volume after the application of the water vapor inyections, known as Rezūm®, in Costa Rican patients of 40 years or older and diagnosed with prostatic bening hyperplasia. Methods Aretrospective study was conducted by reviewing patient records, that were intervened at UNIBE Hospi- tal, in Costa Rica. Prostatic volume was specified as the main variable to asses reversion of prostatic bening hyperplasia. Other variables like the International Prostatic Syntome Score were also assessed. A total of 318 record patients were identified to be included in the study. A mean comparison of previous and posterior meassures of the prostatic volume were collected from the clinical records,stating an alternative hypothesis of mean difference greater than 15 points in reduction of the prostatic volume. Type I error wasset at 0.01 in order to evaluate the consistency of the outcome at a rigouros level. Results After data extraction from the clinical records, patients that had complete values for this assessment were 286 in total, leaving only the 10 % of initial aimed patients. The prostatic volume initial measure mean was 46.93 units with a standarddeviation of 13.98 units, and the posterior mean was estimated at 25.96 with a standard deviation of 9.12. After statistical comparison, this reduction was significant for the observed evidence. A difference between the sample means can be expectto be as extreme as 20.97 units with a p-value < 0.0001 % of the time under the null hypothesis. Therefore, there is sufficientevidence to reject the null hypothesis. Conclusion There is enough evidence to expect an effective reduction on the prostatic volume  when  aplying  Rezūm® water vapor  therapy  in  Costa  Rican  men.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06315062

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

A protocol was submitted, reviewed and approved by the ethics commitee of CEC UNIBE and was registered with the code CEC-UNIBE CEC-07-2023.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All relevant data are within the manuscript and its Supporting Information files. If requested data can be available vía email.

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