Benign Hyperplasia of ProstateNCT06315062
Efficacy of Rezum® in Reducing Prostate Volume
An observational study of Benign Hyperplasia of Prostate, run by Urología Costa Rica at 1 site in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Hyperplasia of Prostate
- How many people
- 289 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men who received Rezum therapy
- Men who have been treated at the UNIBE Hospital in Urology by Dr. González
Who cannot join
- Patients without complete data for the previous variables
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Rezum® in Reducing Prostate Volume. A Retrospective Study in Patients With Benign Hyperplasia in Costa Rica
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.
Read the 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.
- Conditions
- Benign Hyperplasia of Prostate
- Keywords
- Prostate, Urology, IPSS score, clinical efficacy, Rezum
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate volume
Prostate volume
Measured: at 0, 1, 3 and 6 months.
Secondary outcomes (2)
International Prostate Symptome Score
International Prostate Symptome Score, minimun score is 0 with midly simptomatic and 35 is the maximun value meaning severely symptomatic
Measured: at 0, 1, 3 and 6 months.
Urinary flow rate
Urinary flow rate
Measured: at 0, 1, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Hyperplasia of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urología Costa Rica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario González, Urología Costa Rica
- Investigators
- Mario González Salas, Dr., Principal investigator, Hospital UNIBEMilena Castro Mora, PhD., Study director, Universidad de Costa Rica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315062
- Sponsor's protocol ID
- CEC-UNIBE-07-2023
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rezum® in Reducing Prostate Volume. A Retrospective Study in Patients With Benign Hyperplasia in Costa Rica
- ClinicalTrials.gov ID
- NCT06315062
- Acronym / sponsor ID
- CEC-UNIBE-07-2023
- Conditions
- Benign Hyperplasia of Prostate
- Keywords
- Prostate, Urology, IPSS score, clinical efficacy, Rezum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Urología Costa RicaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Men who received Rezum therapy
- Men who have been treated at the UNIBE Hospital in Urology by Dr. González
Key exclusion criteria (1 listed)
- Patients without complete data for the previous variables
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prostate volume
Time frame: at 0, 1, 3 and 6 months.
Prostate volume
2 secondary outcomes
International Prostate Symptome Score
Time frame: at 0, 1, 3 and 6 months.
Urinary flow rate
Time frame: at 0, 1, 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario González Salas, Dr. principal investigator
Hospital UNIBE
Milena Castro Mora, PhD. study director
Universidad de Costa Rica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Hyperplasia of Prostate, run by Urología Costa Rica at 1 site in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate volume (time frame: at 0, 1, 3 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.