Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Benign prostatic hyperplasia, Rezum, MRI-TRUS
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.
Interventions
PROCEDURETransurethral Thermal Vaporization of the Prostate
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.
DEVICERezūm Water Vapor Thermal Therapy System
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. The treatment is performed under cystoscopic and transrectal ultrasound (TRUS) guidance with electromagnetic navigation.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume changes in the prostate transition zone | From enrollment to 6 months after surgery | The volume of the transitional zone measured by MRI before and 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostatic volume change | From enrollment to 6 months after surgery | Changes in prostate volume before and 6 months after surgery |
| IPSS | From enrollment to 6 months after surgery | 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. |
| Qmax | From enrollment to 6 months after surgery | Maximum urine flow rate |
| PVR | From enrollment to 6 months after surgery | Post-Void Residual urine |
| 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. | — |
| Quality of Life Score | From enrollment to 6 months after surgery | 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. |
| Prostate Transition Zone Volume Measured by Transrectal Ultrasound | Baseline, 1 week, 1 month, 3 months, and 6 months after surgery | 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). |
| Total Prostate Volume Measured by Transrectal Ultrasound | Baseline, 1 week, 1 month, 3 months, and 6 months after surgery | 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). |
Countries
China
Contacts
CONTACTQing Yuan, Doctor of Medicine
Outcome results
None listed