PROSTATE CANCER
Conditions
Interventions
Single arm:Minimally invasive treatment of benign prostatic hyperplasia represented by high intensity focused ultrasound (HIFU)
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
51 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 50 years; 2. With moderate and severe lower urinary tract symptoms (IPSS >= 8 points); 3. Prostate volume = 26 mL, left and right diameter >= 28 ml.
Exclusion criteria
Exclusion criteria: 1. Previous prostate and rectal surgery; 2. Patients with prostate cancer, lower gastrointestinal cancer and Crohn's disease; 3. Patients with bladder neck contracture, neurogenic bladder and urethral bracketing lesions; 4. Patients with penile implants, pelvic metal implants and pacemakers; 5. Prostate upper and lower diameter > 4.0 cm; 6. Patients with urinary system infection that has not been cured; patients with severe calcifications in the prostate that may affect HIFU treatment; 7. Patients who are taking the following drugs, including amitriptyline, protriptyline, diphenhydramine, benzoxapine, trihexyline, haloperidol, thioridazine, hydrochlorothiazide, dicyclomine, glycopyrrolate, atropine, belladonna, hydroxylamine, levodopa, isoproterenol, terbutaline, isoproterenol, isoproterenol, pseudoephedrine, phenylpropanolamine, dextroamphetamine and methylphenidate; 8. Anesthesiologists evaluate patients who are not suitable for general anesthesia or spinal anesthesia; 9. Patients with tPSA > 4.0 ng/mL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in international prostate symptom score (IPSS) at 180 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Qmax from baseline at 180 days after operation;Changes of IPSS and Qmax from baseline at other visit points;Change of prostate volume from baseline at each visit point; | — |
Countries
China
Contacts
Public ContactWang Xin
Beijing Hospital
Outcome results
None listed