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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Qing Yuan, Doctor of Medicine
qyuanmd@outlook.com
8601018910980422
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Rezum
Participants in this group will undergo transurethral thermal vaporization of the prostate.
Related Therapeutic Areas
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov