Benign Prostatic Hyperplasia (BPH)NCT06817733
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
A study testing Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy and Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation in people with Benign Prostatic Hyperplasia (BPH), run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study evaluates a new imaging-guided approach for treating benign prostatic hyperplasia (BPH), also known as enlarged prostate. BPH is a common condition in older men that can cause bothersome urinary symptoms. 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?
- Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy and Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation
- Type of treatment
- Injection or infusion, 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.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Qing Yuan, 8618910980422, qyuanmd@outlook.com
Yuan, qyuanmd@outlook.com
About this study
This study evaluates a new imaging-guided approach for treating benign prostatic hyperplasia (BPH), also known as enlarged prostate.
BPH is a common condition in older men that can cause bothersome urinary symptoms. Water vapor thermal therapy (Rezūm) is an FDA-approved and NMPA-approved treatment that uses steam to shrink the enlarged prostate. Traditionally, this procedure is performed using ultrasound guidance alone.
Read more
This study uses an advanced imaging technique that combines MRI (magnetic resonance imaging) with real-time ultrasound and electromagnetic navigation. This combination allows doctors to see the prostate more clearly and deliver the steam treatment more precisely to the areas that need it.
The study will examine:
- Whether this imaging-guided approach can effectively reduce prostate size and improve urinary symptoms
- How safe this treatment method is
- Whether the advanced imaging helps target the treatment more accurately Participants will undergo the steam treatment procedure and will be followed for 6 months with regular check-ups, questionnaires about their urinary symptoms, and imaging tests to measure changes in prostate size.
Read the detailed description
Objective of the Clinical Trial
This is a prospective, single-arm exploratory study to evaluate the safety and preliminary efficacy of MRI/TRUS fusion-guided water vapor thermal therapy with electromagnetic navigation for the treatment of benign prostatic hyperplasia (BPH).
Conventional water vapor thermal therapy relies solely on transrectal ultrasound (TRUS) guidance, which may have limitations in accurately targeting hyperplastic prostatic tissue, particularly in the transition zone. This study introduces an innovative approach by integrating preoperative multiparametric MRI with real-time TRUS using electromagnetic navigation technology. This fusion imaging technique enables more precise identification of target tissue and more accurate delivery of thermal energy, potentially resulting in more uniform ablation of hyperplastic tissue and improved clinical outcomes.
The primary questions this study aims to address are:
- What is the efficacy of MRI/TRUS fusion-guided water vapor thermal therapy in reducing prostate volume and alleviating lower urinary tract symptoms (LUTS) in patients with BPH?
- What is the safety profile of this image-guided treatment approach?
- Can MRI/TRUS fusion with electromagnetic navigation achieve precise targeting and uniform distribution of thermal ablation within the prostate?
Study Procedures
Preoperative Evaluation:
Participants will undergo comprehensive preoperative assessments, including:
- Clinical examination and medical history
- International Prostate Symptom Score (IPSS) questionnaire and Quality of Life assessment
- Uroflowmetry (maximum urinary flow rate, Qmax) and post-void residual urine volume (PVR) measurement
- Laboratory tests (including PSA, urinalysis, and routine blood tests)
- Multiparametric MRI of the prostate for treatment planning and target identification
Procedure:
Participants will receive precise prostate water vapor thermal therapy under MRI/TRUS fusion guidance with electromagnetic navigation. The preoperative MRI will be registered and fused with intraoperative transrectal ultrasound images in real-time, allowing the surgical team to accurately identify target tissue and deliver thermal energy to predetermined treatment zones. The electromagnetic navigation system tracks the position of the treatment device, ensuring precise needle placement and optimal distribution of water vapor throughout the hyperplastic tissue.
Postoperative Follow-up:
Participants will be followed at regular intervals: 1 week, 1 month, 3 months, and 6 months after surgery. Follow-up assessments will include:
- Reassessment of prostate volume by MRI (at 6 months) and transrectal ultrasound (at all time points)
- International Prostate Symptom Score (IPSS) questionnaire and Quality of Life Score
- Measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR)
- Assessment of treatment-related adverse events and complications
- Evaluation of sexual function
Research Team
A multidisciplinary research team at Chinese PLA General Hospital, consisting of urologists, radiologists, and medical imaging specialists, will perform the MRI/TRUS fusion-guided water vapor thermal therapy procedures and conduct comprehensive follow-up assessments for all participants.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy, Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation
- 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.
Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal TherapyProcedure 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 deployment delivers steam for 9 seconds, and multiple injections are performed to achieve comprehensive coverage of the hyperplastic tissue. The entire treatment is typically completed within 3-5 minutes after the first needle insertion.
Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic NavigationDevice
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.
In this study, the Rezūm treatment is performed using an integrated image guidance platform that combines:
- Preoperative multiparametric MRI for detailed visualization and treatment planning
- Real-time transrectal ultrasound (TRUS) for intraoperative imaging
- Electromagnetic navigation technology for real-time tracking of instrument position
- Image fusion software that registers and merges preoperative MRI with intraoperative TRUS images This integrated approach enables precise targeting of hyperplastic tissue, accurate needle placement, and optimal distribution of thermal energy throughout the treatment zone.
| Study group | Role | What they receive |
|---|---|---|
| Rezum | Experimental | Participants in this group will undergo transurethral thermal vaporization of the prostate. Receives: Procedure: Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy; Device: Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume changes in the prostate transition zone
Change in prostate transition zone volume measured by MRI from baseline to 6 months post-treatment. This outcome assesses the ablative efficacy of MRI/TRUS fusion-guided water vapor therapy. The hypothesis is that precise image-guided targeting will result in more uniform thermal energy distribution and more effective volume reduction compared to historical data from conventional TRUS-guided approaches.
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.
- 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.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817733
- Sponsor's protocol ID
- REZUM2025
- Status last verified
- Nov 2026
- First submitted
- 4 Feb 2025
- Last updated
- 5 Nov 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 33403529Ines 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 34254333McVary 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 33872051McVary 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 26614889McVary 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 30677455Sandhu 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 37706750Zhang 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 31221864Lee 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 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.
This study evaluates a new imaging-guided approach for treating benign prostatic hyperplasia (BPH), also known as enlarged prostate.
BPH is a common condition in older men that can cause bothersome urinary symptoms. Water vapor thermal therapy (Rezūm) is an FDA-approved and NMPA-approved treatment that uses steam to shrink the enlarged prostate. Traditionally, this procedure is performed using ultrasound guidance alone.
This study uses an advanced imaging technique that combines MRI (magnetic resonance imaging) with real-time ultrasound and electromagnetic navigation. This combination allows doctors to see the prostate more clearly and deliver the steam treatment more precisely to the areas that need it.
The study will examine:
- Whether this imaging-guided approach can effectively reduce prostate size and improve urinary symptoms
- How safe this treatment method is
- Whether the advanced imaging helps target the treatment more accurately Participants will undergo the steam treatment procedure and will be followed for 6 months with regular check-ups, questionnaires about their urinary symptoms, and imaging tests to measure changes in prostate size.
Detailed description
Objective of the Clinical Trial
This is a prospective, single-arm exploratory study to evaluate the safety and preliminary efficacy of MRI/TRUS fusion-guided water vapor thermal therapy with electromagnetic navigation for the treatment of benign prostatic hyperplasia (BPH).
Conventional water vapor thermal therapy relies solely on transrectal ultrasound (TRUS) guidance, which may have limitations in accurately targeting hyperplastic prostatic tissue, particularly in the transition zone. This study introduces an innovative approach by integrating preoperative multiparametric MRI with real-time TRUS using electromagnetic navigation technology. This fusion imaging technique enables more precise identification of target tissue and more accurate delivery of thermal energy, potentially resulting in more uniform ablation of hyperplastic tissue and improved clinical outcomes.
The primary questions this study aims to address are:
- What is the efficacy of MRI/TRUS fusion-guided water vapor thermal therapy in reducing prostate volume and alleviating lower urinary tract symptoms (LUTS) in patients with BPH?
- What is the safety profile of this image-guided treatment approach?
- Can MRI/TRUS fusion with electromagnetic navigation achieve precise targeting and uniform distribution of thermal ablation within the prostate?
Study Procedures
Preoperative Evaluation:
Participants will undergo comprehensive preoperative assessments, including:
- Clinical examination and medical history
- International Prostate Symptom Score (IPSS) questionnaire and Quality of Life assessment
- Uroflowmetry (maximum urinary flow rate, Qmax) and post-void residual urine volume (PVR) measurement
- Laboratory tests (including PSA, urinalysis, and routine blood tests)
- Multiparametric MRI of the prostate for treatment planning and target identification
Procedure:
Participants will receive precise prostate water vapor thermal therapy under MRI/TRUS fusion guidance with electromagnetic navigation. The preoperative MRI will be registered and fused with intraoperative transrectal ultrasound images in real-time, allowing the surgical team to accurately identify target tissue and deliver thermal energy to predetermined treatment zones. The electromagnetic navigation system tracks the position of the treatment device, ensuring precise needle placement and optimal distribution of water vapor throughout the hyperplastic tissue.
Postoperative Follow-up:
Participants will be followed at regular intervals: 1 week, 1 month, 3 months, and 6 months after surgery. Follow-up assessments will include:
- Reassessment of prostate volume by MRI (at 6 months) and transrectal ultrasound (at all time points)
- International Prostate Symptom Score (IPSS) questionnaire and Quality of Life Score
- Measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR)
- Assessment of treatment-related adverse events and complications
- Evaluation of sexual function
Research Team
A multidisciplinary research team at Chinese PLA General Hospital, consisting of urologists, radiologists, and medical imaging specialists, will perform the MRI/TRUS fusion-guided water vapor thermal therapy procedures and conduct comprehensive follow-up assessments for all participants.
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: Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy, Device: Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic NavigationParticipants 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 |
|---|---|---|
| Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal TherapyAfter 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 deployment delivers steam for 9 seconds, and multiple injections are performed to achieve comprehensive coverage of the hyperplastic tissue. The entire treatment is typically completed within 3-5 minutes after the first needle insertion. | Procedure or surgery | Rezum |
| Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic NavigationThe 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. In this study, the Rezūm treatment is performed using an integrated image guidance platform that combines: 1. Preoperative multiparametric MRI for detailed visualization and treatment planning 2. Real-time transrectal ultrasound (TRUS) for intraoperative imaging 3. Electromagnetic navigation technology for real-time tracking of instrument position 4. Image fusion software that registers and merges preoperative MRI with intraoperative TRUS images This integrated approach enables precise targeting of hyperplastic tissue, accurate needle placement, and optimal distribution of thermal energy throughout the treatment zone. | Device | Rezum |
Primary outcome
Volume changes in the prostate transition zone
Time frame: From enrollment to 6 months after surgery
Change in prostate transition zone volume measured by MRI from baseline to 6 months post-treatment. This outcome assesses the ablative efficacy of MRI/TRUS fusion-guided water vapor therapy. The hypothesis is that precise image-guided targeting will result in more uniform thermal energy distribution and more effective volume reduction compared to historical data from conventional TRUS-guided approaches.
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 5 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy and Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation in people with Benign Prostatic Hyperplasia (BPH), run by Chinese PLA General Hospital at 1 site in China.
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 5 Nov 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 5 Nov 2026.