Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezum | Experimental | Participants in this group will undergo transurethral thermal vaporization of the prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prostatic volume change | Changes in prostate volume before and 6 months after surgery | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Yuan, Doctor of Medicine | Contact | 8601018910980422 | qyuanmd@outlook.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33403529 | Result | 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. | |
| 34254333 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From enrollment to 6 months after surgery |
| Qmax | Maximum urine flow rate | From enrollment to 6 months after surgery |
| PVR | Post-Void Residual urine | 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. |
| 33872051 | 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. |
| 26614889 | 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. |
| 30677455 | 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. |
| 37706750 | 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. |
| 31221864 | 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. |
| 28801563 | 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. |
| D052801 |
| Male Urogenital Diseases |