Clinical trial NCT06817733: Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Official title: Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia
Rezum
MRI-TRUS
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Volume changes in the prostate transition zone
timeFrame: From enrollment to 6 months after surgery
Secondary outcomes:
measure: Prostatic volume change
timeFrame: From enrollment to 6 months after surgery
measure: IPSS
timeFrame: From enrollment to 6 months after surgery
measure: Qmax
timeFrame: From enrollment to 6 months after surgery
measure: PVR
timeFrame: From enrollment to 6 months after surgery
measure: Duration of postoperative indwelling urinary catheter
timeFrame: From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.