Benign Prostatic Hyperplasia (BPH)NCT06817733

Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging

A study testing Transurethral Thermal Vaporization of the Prostate and Rezūm Water Vapor Thermal Therapy System in people with Benign Prostatic Hyperplasia (BPH), run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Objective of the Clinical Trial The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. Read more about this study

Who is it for?: Ages 45 to 85 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: Transurethral Thermal Vaporization of the Prostate and Rezūm Water Vapor Thermal Therapy System
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 15 Apr 2025to 30 Jun 2027
Phase: Interventional
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 45 to 85 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 45-85 years;
International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;
Poor response to pharmacological treatment or refusal of pharmacological treatment;
Prostate volume 30-80 mL;
Maximum urinary flow rate (Qmax) < 15 mL/s;
Post-void residual urine volume (PVR) < 300 mL;
Willingness to provide informed consent and participate in postoperative follow-up.

Who cannot join

Prostate volume < 30 mL or > 80 mL;
Severe urinary tract infection;
Preoperative definitive diagnosis of prostate cancer;
Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
Patients with prostatitis;
History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qing Yuan, Doctor of Medicine contact

8601018910980422

qyuanmd@outlook.com

China1 site, 1 recruiting

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Qing Yuan, 8618910980422, qyuanmd@outlook.com
Yuan, qyuanmd@outlook.com
Recruiting

Other trials in China

About this study

Objective of the Clinical Trial

The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are:

Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests.

Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance.

Postoperative Follow-up:

Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire.

Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR).

Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: Transurethral Thermal Vaporization of the Prostate, Rezūm Water Vapor Thermal Therapy System
Keywords: Benign prostatic hyperplasia, Rezum, MRI-TRUS
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transurethral Thermal Vaporization of the ProstateProcedure or surgery
After anesthesia, the patient is placed in the lithotomy position, and standard aseptic preparation and draping are performed. A cystoscope and a transrectal ultrasound (TRUS) probe are inserted. Following real-time image fusion and localization according to the preoperative plan, needles are inserted to deliver thermal vaporization to the prostate. Each needle treatment lasts 8 seconds, and the entire procedure is completed within 200 seconds after activation of the needle pathway.
Rezūm Water Vapor Thermal Therapy SystemDevice
The Rezūm System is an FDA-cleared and NMPA-approved transurethral water vapor thermal therapy device for the treatment of benign prostatic hyperplasia (BPH). The system delivers thermal energy in the form of water vapor to ablate hyperplastic prostate tissue. The treatment is performed under cystoscopic and transrectal ultrasound (TRUS) guidance with electromagnetic navigation.

Study groups in NCT06817733
Study group	Role	What they receive
Rezum	Experimental	Participants in this group will undergo transurethral thermal vaporization of the prostate. Receives: Procedure: Transurethral Thermal Vaporization of the Prostate; Device: Rezūm Water Vapor Thermal Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume changes in the prostate transition zone
The volume of the transitional zone measured by MRI before and 6 months after surgery
Measured: From enrollment to 6 months after surgery

Secondary outcomes (8)

Prostatic volume change
Changes in prostate volume before and 6 months after surgery
Measured: From enrollment to 6 months after surgery
IPSS
International Prostate Symptom Score.The minimum IPSS score was 0, the maximum was 35, and the higher the score, the more severe the lower urinary tract symptoms were. 0-7 was classified as mild symptoms, 8-19 as moderate symptoms, and 20-35 as severe symptoms.
Measured: From enrollment to 6 months after surgery
Qmax
Maximum urine flow rate
Measured: From enrollment to 6 months after surgery
PVR
Post-Void Residual urine
Measured: From enrollment to 6 months after surgery
Duration of postoperative indwelling urinary catheter
Measured: From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.
Quality of Life Score
Quality of life related to urinary symptoms, assessed using the International Prostate Symptom Score Quality of Life (IPSS-QoL) questionnaire. The QoL score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating worse quality of life.
Measured: From enrollment to 6 months after surgery
Prostate Transition Zone Volume Measured by Transrectal Ultrasound
Changes in prostate transition zone volume measured by transrectal ultrasound (TRUS) before and after surgery. Volume is calculated using the ellipsoid formula and measured in milliliters (mL).
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
Total Prostate Volume Measured by Transrectal Ultrasound
Changes in total prostate volume measured by transrectal ultrasound (TRUS) before and after surgery. Volume is calculated using the ellipsoid formula and measured in milliliters (mL).
Measured: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202530 Jun 2027

First posted10 Feb 2025
Study start15 Apr 2025
Primary completion30 Dec 2026 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06817733
Sponsor's protocol ID: REZUM2025
Status last verified: Aug 2026
First submitted: 4 Feb 2025
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Doppalapudi SK, Gupta N. What Is New with Rezum Water Vapor Thermal Therapy for LUTS/BPH? Curr Urol Rep. 2021 Jan 6;22(1):4. doi: 10.1007/s11934-020-01018-6.
PubMed 33403529
Ines M, Babar M, Singh S, Iqbal N, Ciatto M. Real-world evidence with The Rezum System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes. Prostate. 2021 Sep;81(13):956-970. doi: 10.1002/pros.24191. Epub 2021 Jul 12.
PubMed 34254333
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
McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
PubMed 26614889
McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
PubMed 30677455
Sandhu JS, Bixler BR, Dahm P, Goueli R, Kirkby E, Stoffel JT, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024 Jan;211(1):11-19. doi: 10.1097/JU.0000000000003698. Epub 2023 Sep 14.
PubMed 37706750
Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.
PubMed 31221864
Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8.
PubMed 28801563

Interested in taking part?

Qing Yuan, Doctor of Medicine

8601018910980422

qyuanmd@outlook.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
ClinicalTrials.gov ID: NCT06817733
Acronym / sponsor ID: REZUM2025
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia, Rezum, MRI-TRUS
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Chinese PLA General HospitalUniversity, hospital or other
Study start: 15 Apr 2025 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 10 Feb 2025 (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.

Objective of the Clinical Trial

Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance.

Postoperative Follow-up:

Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire.

Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR).

Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rezum	Experimental	Procedure: Transurethral Thermal Vaporization of the Prostate, Device: Rezūm Water Vapor Thermal Therapy SystemParticipants in this group will undergo transurethral thermal vaporization of the prostate.

Who may qualify

Ages: 45 to 85 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 45-85 years;
International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;
Poor response to pharmacological treatment or refusal of pharmacological treatment;
Prostate volume 30-80 mL;
Maximum urinary flow rate (Qmax) < 15 mL/s;

Key exclusion criteria (7 listed)

Prostate volume < 30 mL or > 80 mL;
Severe urinary tract infection;
Preoperative definitive diagnosis of prostate cancer;
Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
Patients with prostatitis;

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
Transurethral Thermal Vaporization of the ProstateAfter anesthesia, the patient is placed in the lithotomy position, and standard aseptic preparation and draping are performed. A cystoscope and a transrectal ultrasound (TRUS) probe are inserted. Following real-time image fusion and localization according to the preoperative plan, needles are inserted to deliver thermal vaporization to the prostate. Each needle treatment lasts 8 seconds, and the entire procedure is completed within 200 seconds after activation of the needle pathway.	Procedure or surgery	Rezum
Rezūm Water Vapor Thermal Therapy SystemThe Rezūm System is an FDA-cleared and NMPA-approved transurethral water vapor thermal therapy device for the treatment of benign prostatic hyperplasia (BPH). The system delivers thermal energy in the form of water vapor to ablate hyperplastic prostate tissue. The treatment is performed under cystoscopic and transrectal ultrasound (TRUS) guidance with electromagnetic navigation.	Device	Rezum

Primary outcome

Volume changes in the prostate transition zone
Time frame: From enrollment to 6 months after surgery
The volume of the transitional zone measured by MRI before and 6 months after surgery

8 secondary outcomes

Prostatic volume change
Time frame: From enrollment to 6 months after surgery
IPSS
Time frame: From enrollment to 6 months after surgery
Qmax
Time frame: From enrollment to 6 months after surgery
PVR
Time frame: From enrollment to 6 months after surgery
Duration of postoperative indwelling urinary catheter
Time frame: From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.
Quality of Life Score
Time frame: From enrollment to 6 months after surgery
Prostate Transition Zone Volume Measured by Transrectal Ultrasound
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
Total Prostate Volume Measured by Transrectal Ultrasound
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery

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 11 Aug 2026.
Results publication: PubMed 33403529Doppalapudi SK, Gupta N. What Is New with Rezum Water Vapor Thermal Therapy for LUTS/BPH? Curr Urol Rep. 2021 Jan 6;22(1):4. doi: 10.1007/s11934-020-01018-6.
Results publication: PubMed 34254333Ines M, Babar M, Singh S, Iqbal N, Ciatto M. Real-world evidence with The Rezum System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes. Prostate. 2021 Sep;81(13):956-970. doi: 10.1002/pros.24191. Epub 2021 Jul 12.
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.
Results publication: PubMed 26614889McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
Results publication: PubMed 30677455McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
Results publication: PubMed 37706750Sandhu JS, Bixler BR, Dahm P, Goueli R, Kirkby E, Stoffel JT, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024 Jan;211(1):11-19. doi: 10.1097/JU.0000000000003698. Epub 2023 Sep 14.
Results publication: PubMed 31221864Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.
Results publication: PubMed 28801563Lee SWH, Chan EMC, Lai YK. The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis. Sci Rep. 2017 Aug 11;7(1):7984. doi: 10.1038/s41598-017-06628-8.
Individual participant dataSharing planned: No

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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.

Qing Yuan, Doctor of Medicine contact

8601018910980422

qyuanmd@outlook.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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 11 Aug 2026. 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 China. 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 Qing Yuan, Doctor of Medicine (8601018910980422, qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume changes in the prostate transition zone (time frame: From enrollment to 6 months after surgery). 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 NCT06817733, which also lists 8 linked publications.

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 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.