Benign Prostatic Hyperplasia
Conditions
Interventions
Experimental group:Percutaneous tibial nerve stimulation
Control group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants have been fully informed of the potential benefits and risks associated with the trial and have provided written consent to participate. 2. Male participants between the ages of 45 and 80 are eligible to participate in the trial. 3. Participants with a confirmed diagnosis of Benign Prostatic Hyperplasia, a maximum urinary flow rate of <=15 ml/sec, undergoing surgical treatment (Thulium laser vapoenucleation) and fulfilling any one of the following conditions according to the International Prostate Symptom Score (IPSS): a) any single IPSS urinary storage subscore (urinary frequency, urgency, nocturia frequency) greater than or equal to 3 points; b) a total IPSS storage subscore of 9 points or greater; 4. Participants who are able to discontinue relevant medications (Appendix 1) for a period of at least one week prior to enrolment; 5.Participants with autonomy, self-care, self-control and the ability to use the toilet independently.
Exclusion criteria
Exclusion criteria: 1. Subjects presenting with urinary incontinence due to reduced sphincter function, or subjects evaluated for neurogenic bladder; 2. Subjects with urethral strictures or bladder neck contractures that make insertion of devices difficult; 3. Subjects with pacemakers, buried cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral neuromodulation). 4. Subjects with implanted devices in the body; 5. Subjects with untreated urinary tract infections; 6. Subjects with urinary stones that cause lower urinary tract symptoms; 7. Subjects with previous pelvic surgery; and 8. Subjects with a history of previous pelvic surgery, colorectal surgery (except polypectomy and haemorrhoidectomy); 9. Subjects with untreated malignant tumours; 10. Subjects with neurological or cerebrovascular lesions or injuries, or medical conditions affecting cognition, bladder function, sphincter function, or urethral muscle function; 11. Subjects with skin breakdown, malignant tumours or acute purulent inflammation on the surface of the plantar foot at the location where the electrode pads are to be placed;11. Subjects who have participated in a clinical trial of another drug within three months or a clinical trial of another medical device within 30 days; 12. Other conditions that the investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptoms Score improvement percentage;Quality of Life change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Qmax change;Overactive Bladder Symptom Score change percentage; | — |
Countries
China
Contacts
Public ContactZhu Yiping
Shanghai First People's Hospital
Outcome results
None listed