benign prostatic hyperplasia
Conditions
Interventions
Test group:intraspinal anesthesia
Control test:general anesthesia
Sponsors
The First Affiliated Hospital of the Chinese People's Liberation Army Naval Military Medical University
Eligibility
Sex/Gender
Male
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 45 years; 2. Lower urinary tract symptom score IPSS >= 13; 3. Maximum urine flow rate QMax <= 15 ml/s; 4. Post void residual of <= 250 mL. 5. The patients should be willing and able to read, understand and sign the informed consent for this study; 6. Participants agree to comply with protocol requirements and all follow-up visits until completion of the 90-day treatment follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous rectal surgery; 2. Inflammatory bowel disease with rectal involvement such as Crohn’s disease or ulcerative colitis; 3. Any metal implants or stents in the urethra, within the area to be ablated; 4. Patients who had undergone brachytherapy near the posterior prostatic capsule, fascia, or rectal wall; 5. Rectal Stenosis; 6. Significant (> 10 mm) fluid-filled cavities (for example, cysts) within the planned ablation zone; 7. Patients with a neurogenic bladder (e.g., paraplegia, stroke, neurological disease, or diabetes); 8. Significant Calcium deposits (> 10 mm) at or near the site of treatment that can block ultrasound from reaching the planned treatment zone; 9. Acute prostatitis; 10. PSA > 4 ng/dL, and pathological results of prostate biopsy are malignant; 11. Prostate AP height > 4.5 cm; 12. If the prostate volume is =80cc, the clinician should make a judgment ; 13. Patients with plans to have children in the future; 14. Patients with known bleeding disorders; 15. Patients who have anatomy that could restrict Sonablate HIFU probe insertion; 16. Patients whose prostate could not be adequately observed by transrectal ultrasound before treatment; 17. Any patient presenting with urinary tract infection must be satisfactorily treated with antibiotics (as determined by confirmatory sterile urine culture) prior to treatment; 18. Candidates will also be excluded if they are known to have an allergic response to latex; 19. Inability to tolerate general anesthesia; 20. Inability to tolerate intraspinal anesthesia; 21. Patients who have participated or have participated in other clinical studies within the past 30 days; 22. Any other circumstances deemed inappropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of international prostate symptom score (IPSS) from baseline to 90 d; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of inflammatory factors (IL-1,6,8,10,TNF-a,CRP) from baseline to 7 d;The change of testosterone from baseline to 7 d;Changes of mini-mental state examination (MMSE) scores from baseline to 24 h after surgery, 30 d 60 d and 90 d;The change of clock drawing test (CDT) score at 24 h after surgery from baseline;Changes of VAS scores at 24h, 30 d, 60 d and 90 d after surgery from baseline;Change in prostate volume at 90d from baseline;Change of prostate ablation at 90d after surgery from baseline;Intraoperative ablation data;Change of serum PSA level at 90d from baseline;Change of Qmax at 90d from baseline;The change of international prostate symptom score (IPSS) from baseline to 30d,60d,90 d;The change of IIEF-5 from baseline to 30d, 60d,90 d;The change of EQ-5D-5l from baseline to 30 d, 60 d,90 d;Length of stay; | — |
Countries
China
Contacts
Public ContactWang Yan
The First Affiliated Hospital of the Chinese People's Liberation Army Naval Military Medical University (Shanghai Changhai Hospital)
Outcome results
None listed