Benign Prostatic HyperplasiaNCT06656689
Study on Water Vapor Thermal Therapy
An observational study of Benign Prostatic Hyperplasia, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is: Is Rezum an effective treatment? Is Rezum safe? Participants will be followed up for at least three months after the treatment to… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Rezum (water vapor thermal therapy)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2023to 31 Oct 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects are patients requiring surgery for benign prostatic hyperplasia (BPH).
Who may be able to join
- Age 50 or older
- Prostate size between 30cc and 80cc as measured by transrectal ultrasound
- Patients scheduled for Rezum surgery for BPH
Who cannot join
- Suspected prostate cancer
- Suspected urinary tract infection
- Inability to complete follow-up
- Patients who do not consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Saint Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Hee Youn Kim, M.D., Ph.D., 82-10-9024-6533, khyoun10589@gmail.com
About this study
Official title: Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients With Benign Prostatic Hyperplasia (BPH)
The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is:
- Is Rezum an effective treatment?
- Is Rezum safe?
Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety.
Read the detailed description
This prospective cohort study aims to evaluate the safety and efficacy of the Rezum procedure, a minimally invasive treatment for benign prostatic hyperplasia (BPH) that utilizes convective water vapor thermal energy. The Rezum procedure was approved by the U.S. FDA in 2015, and recent approval by South Korea's Ministry of Health and Welfare has allowed its use in South Korean patients. Unlike other BPH treatments, Rezum delivers steam at 103°C directly into the prostatic tissue, inducing necrosis and reduction of prostate size through a controlled thermal effect. This process is conducted in a day-surgery setting under local, general, or spinal anesthesia, minimizing patient burden and recovery time.
The study will enroll male patients aged 50 or older with confirmed BPH who meet specific prostate size criteria, measured via transrectal ultrasound. Following a preoperative evaluation, including prostate size, PSA levels, symptom questionnaires, and urodynamic assessment, patients will undergo the Rezum procedure. This involves cystoscope-guided needle insertion into hypertrophic prostate regions, where targeted thermal energy is delivered in short bursts. The procedure is completed within a single hospital visit, and patients are generally discharged on the same day unless complications arise.
After surgery, participants will have routine follow-up visits, including catheter removal and initial voiding assessments within one week. Further follow-up, at a minimum of three months, will include standardized assessments of voiding function, symptom severity (IPSS, IIEF, OAB-q), prostate size, uroflowmetry, and residual urine volume. The safety profile will be assessed by recording adverse events, including infection, hematuria, voiding dysfunction, and the necessity for catheter reinsertion. Complications will be classified according to the Clavien-Dindo classification system.
Data analysis will assess the preoperative and postoperative changes in symptom severity, functional parameters, and prostate measurements. Comparisons of these continuous variables will utilize paired sample t-tests or Wilcoxon signed-rank tests, depending on normality test results. Variables include IPSS, IIEF, OAB-q, prostate size, PSA, maximum flow rate (Qmax), and post-void residual volume (PVR). Additionally, multiple regression analysis will identify factors contributing to the need for postoperative catheter reinsertion. Statistical significance will be set at α=0.05, with p-values below 0.05 indicating significant differences.
This study will address a current gap in research on the Rezum procedure's impact on Korean patients, contributing to the understanding of this minimally invasive approach within different populations and expanding its potential applicability.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Rezum (water vapor thermal therapy)
- Keywords
- Benign Prostatic Hyperplasia, Rezum, Water Vapor Thermal Therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezum (water vapor thermal therapy)Procedure or surgery
Rezum or water vapor thermal therapy is a procedure that involves injecting steam at 103°C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate.
| Study group | Role | What they receive |
|---|---|---|
| Rezum Group | Patients who underwent Rezum water vapor thermal therapy treatment for BPH Receives: Procedure: Rezum (water vapor thermal therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) is a validated, reproducible scoring system to assess disease severity and response to therapy for BPH. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Measured: From enrollment to three months after treatment
Qmax
Maximal urine flow rate in uroflowmetry exam
Measured: From enrollment to three months after treatment
Secondary outcomes (1)
Complications
Complications evaluated using the Clavien-Dindo classification
Measured: Three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start31 Jul 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Youn Kim, Saint Vincent's Hospital, Korea
- Investigators
- Hee Youn Kim, M.D., Ph.D., Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656689
- Sponsor's protocol ID
- SVHWVTT
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request to the PI. The investigators do not have a specific URL to provide the information.
Publications
McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
PubMed 33872051
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients With Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT06656689
- Acronym / sponsor ID
- SVHWVTT
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, Rezum, Water Vapor Thermal Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 24 Oct 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.
The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is:
- Is Rezum an effective treatment?
- Is Rezum safe?
Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety.
Detailed description
This prospective cohort study aims to evaluate the safety and efficacy of the Rezum procedure, a minimally invasive treatment for benign prostatic hyperplasia (BPH) that utilizes convective water vapor thermal energy. The Rezum procedure was approved by the U.S. FDA in 2015, and recent approval by South Korea's Ministry of Health and Welfare has allowed its use in South Korean patients. Unlike other BPH treatments, Rezum delivers steam at 103°C directly into the prostatic tissue, inducing necrosis and reduction of prostate size through a controlled thermal effect. This process is conducted in a day-surgery setting under local, general, or spinal anesthesia, minimizing patient burden and recovery time.
The study will enroll male patients aged 50 or older with confirmed BPH who meet specific prostate size criteria, measured via transrectal ultrasound. Following a preoperative evaluation, including prostate size, PSA levels, symptom questionnaires, and urodynamic assessment, patients will undergo the Rezum procedure. This involves cystoscope-guided needle insertion into hypertrophic prostate regions, where targeted thermal energy is delivered in short bursts. The procedure is completed within a single hospital visit, and patients are generally discharged on the same day unless complications arise.
After surgery, participants will have routine follow-up visits, including catheter removal and initial voiding assessments within one week. Further follow-up, at a minimum of three months, will include standardized assessments of voiding function, symptom severity (IPSS, IIEF, OAB-q), prostate size, uroflowmetry, and residual urine volume. The safety profile will be assessed by recording adverse events, including infection, hematuria, voiding dysfunction, and the necessity for catheter reinsertion. Complications will be classified according to the Clavien-Dindo classification system.
Data analysis will assess the preoperative and postoperative changes in symptom severity, functional parameters, and prostate measurements. Comparisons of these continuous variables will utilize paired sample t-tests or Wilcoxon signed-rank tests, depending on normality test results. Variables include IPSS, IIEF, OAB-q, prostate size, PSA, maximum flow rate (Qmax), and post-void residual volume (PVR). Additionally, multiple regression analysis will identify factors contributing to the need for postoperative catheter reinsertion. Statistical significance will be set at α=0.05, with p-values below 0.05 indicating significant differences.
This study will address a current gap in research on the Rezum procedure's impact on Korean patients, contributing to the understanding of this minimally invasive approach within different populations and expanding its potential applicability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezum Group | – | Procedure: Rezum (water vapor thermal therapy)Patients who underwent Rezum water vapor thermal therapy treatment for BPH |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects are patients requiring surgery for benign prostatic hyperplasia (BPH).
Key inclusion criteria (3 listed)
- Age 50 or older
- Prostate size between 30cc and 80cc as measured by transrectal ultrasound
- Patients scheduled for Rezum surgery for BPH
Key exclusion criteria (4 listed)
- Suspected prostate cancer
- Suspected urinary tract infection
- Inability to complete follow-up
- Patients who do not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezum (water vapor thermal therapy)Rezum or water vapor thermal therapy is a procedure that involves injecting steam at 103°C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate. | Procedure or surgery | Rezum Group |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: From enrollment to three months after treatment
International Prostate Symptom Score (IPSS) is a validated, reproducible scoring system to assess disease severity and response to therapy for BPH. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Qmax
Time frame: From enrollment to three months after treatment
Maximal urine flow rate in uroflowmetry exam
1 secondary outcome
Complications
Time frame: Three months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Results publication: PubMed 33872051McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request to the PI. The investigators do not have a specific URL to provide the information.
Related trials for Benign Prostatic Hyperplasia
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BPH (Benign Prostatic Hyperplasia)
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
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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.
Hee Youn Kim, M.D., Ph.D. principal investigator
St Vincent's Hospital
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 Prostatic Hyperplasia, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hee Youn Kim, M.D., Ph.D. (82-10-9024-6533, khyoun10589@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: From enrollment to three months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656689, which also lists 1 linked publication.
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 6 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.