Benign prostatic hyperplasia
Conditions
Interventions
Trial Group:Disposable sterile transurethral dilation drug balloon catheter system
Control Group:Pseudopregnancy therapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects older than 50 years of age; 2. Subject has been clearly diagnosed with benign prostatic hyperplasia; 3. Subject's International Prostate Symptom Score (IPSS) before surgery >=13 points; 4. The maximum urinary flow rate (Qmax) of the subject before surgery was =125mL; 7. The volume of the subject's prostate before surgery is 30~80cm^3; 8. The subject or his guardian can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject has abnormal renal function (SCr is 1.5 times higher than the upper limit of normal); 2. Subjects had abnormal coagulation function (APTT higher than 2 times the upper limit of normal) before enrollment, and platelet count =1cm (prostate protrusion into the bladder); 7. Have a history of allergic reaction to dexamethasone and are taking drugs that have side effects with dexamethasone; 8. Subject has used antiplatelet or anticoagulant medications within 7 days prior to treatment, with the exception of low-dose aspirin (=10ng/ml before enrollment; 10. Subject has a confirmed diagnosis of epididymitis within 1 month prior to enrollment; 11. Subject has had unstable angina, myocardial infarction, transient ischemic attack, or cerebrovascular accident within 3 months prior to enrollment; 12. Subject has a confirmed diagnosis of bacterial prostatitis within 1 month prior to enrollment; 13. Presence of hematuria prior to enrollment; 14. Presence of penile implants or stents in the urethra or prostate prior to subject enrollment; 15. Subjects have received invasive prostate therapy (e.g., prostate surgery, radiofrequency ablation, microwave ablation, laser ablation, balloon, etc.) before enrollment; 16. Subjects have been diagnosed with malignant tumors or prostate cancer or bladder cancer before enrollment, except for high-grade prostatic intraepithelial neoplasia (PIN); 17. Pelvic irradiation or radical pelvic surgery received by the subject before enrollment; 18. Subject has undergone rectal surgery (except hemorrhoidectomy) prior to enrollment or has known rectal disease; 19. Subjects have confirmed or suspected primary neurological diseases that cause abnormal sphincter or detrusor function, such as multiple sclerosis or Parkinson's disease or other neurological diseases, prior to enrollment; 20. Presence of bladder neck contractures, prostate tip (bulb) contractures, urethral strictures, unusual pelvic anatomy, or muscle spasms prior to enrollment that may prevent the entry and use of the device; 21. Subjects who have participated in any other clinical trials of drugs or medical devices within 3 months prior to screening; 22. Other conditions that the investigator considers the patient not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of the International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum flow rate;Residual urine volume;Total score of symptoms in the Male Sexual health Checklist;Ejaculation function score of Male Sexual Health Questionnaire for Ejaculation dysfunction;Urinary incontinence severity index; | — |
Countries
China
Contacts
Public ContactZhang Kai
Peking University First Hospital
Outcome results
None listed