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

NCT06817733 | Recruiting FDA Device

• 1 other identifier: REZUM2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Benign prostatic hyperplasia; Rezum; MRI-TRUS

Outcome Measures

Primary Outcomes (1)

• Volume changes in the prostate transition zone

  The volume of the transitional zone measured by MRI before and 6 months after surgery

  From enrollment to 6 months after surgery

Secondary Outcomes (5)

• Prostatic volume change

  From enrollment to 6 months after surgery

• IPSS

  From enrollment to 6 months after surgery

• Qmax

  From enrollment to 6 months after surgery

• PVR

  From enrollment to 6 months after surgery

• Duration of postoperative indwelling urinary catheter

  From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.

Study Arms (1)

Rezum

EXPERIMENTAL

Participants in this group will undergo transurethral thermal vaporization of the prostate.

Procedure: Transurethral Thermal Vaporization of the Prostate

Interventions

Transurethral Thermal Vaporization of the Prostate PROCEDURE

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.

Rezum

Eligibility Criteria

• Age: 45 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 33403529 RESULT

• 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.

  PMID: 34254333 RESULT

• 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.

  PMID: 33872051 RESULT

• 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.

  PMID: 26614889 RESULT

• 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.

  PMID: 30677455 RESULT

• 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.

  PMID: 37706750 RESULT

• 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.

  PMID: 31221864 RESULT

• 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.

  PMID: 28801563 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Qing Yuan, Doctor of Medicine

CONTACT

8601018910980422; qyuanmd@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 15, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)