Benign Prostatic Hyperplasia
Conditions
Interventions
Experimental group:Percutaneous tibial nerve electrical stimulation and routine care
Control group:routine care
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male subjects aged 40 years or older; 2. Diagnosed with benign prostatic hyperplasia according to the "Guidelines for the Diagnosis and Treatment of Benign Prostatic Hyperplasia" in the 2022 edition of the "Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases"; 3. Preoperative patients scheduled to undergo transurethral thulium laser enucleation of the prostate; 4. At least primary school education, conscious, and able to communicate verbally; 5. Subjects fully understand the benefits and risks of this trial, are willing to participate, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who, for various reasons, did not undergo the planned transurethral thulium laser prostatectomy during this hospitalization; 2. Subjects assessed as having neurogenic bladder; 3. Those with urethral stricture or bladder neck contracture that makes instrument insertion difficult; 4. Subjects with implanted pacemakers, subcutaneous implantable cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral nerve modulation devices); 5. Subjects with congenital urinary tract malformations causing untreated lower urinary tract symptoms; 6. Subjects with a history of pelvic surgery or colorectal surgery (excluding polypectomy or hemorrhoidectomy); 7. Subjects with untreated malignant tumors; 8. Those with coagulation disorders or bleeding tendencies; 9. Subjects with skin damage, malignant tumors, or acute purulent inflammation at the planned site of electrode placement on the sole of the foot; 10. Subjects with metal objects on or inside the site where electrodes are to be placed on the sole; 11. Those who have participated in other drug clinical trials within 3 months or in other medical device clinical trials within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of bladder spasms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of bladder spasms (times per 24 hours);Duration of bladder spasm (minutes);Intensity of bladder spasm;The time of the first seizure occurrence;Pain score;Duration of urinary catheter placement;The rate of urinary catheter blockage;Blood transfusion rate;The rate of secondary surgeries;Hospitalization period; | — |
Countries
China
Contacts
Public ContactDuan Xiaolei
Shanghai General Hospital
Outcome results
None listed