overactive bladder
Conditions
Interventions
Experimental group:True electrical stimulation treatment
Control group:Fake electrical stimulation treatment
Sponsors
China Rehabilitation Research Center, Beijing Bo'ai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (including boundary value), gender is not limited; 2. Meet the diagnostic criteria for overactive bladder in the 2019 Edition of Chinese Guidelines for Diagnosis and Treatment of Urology and Andrology Diseases; 3. Agree to receive wearable transcutaneous tibial nerve stimulator treatment; 4. Participate in the clinical trial voluntarily and sign the informed consent; 5. Patients who are not satisfied with the efficacy of ß3 receptor agonists or anticholinergic drugs, or who are intolerant to adverse reactions caused by anticholinergic drugs, or who are unwilling to take oral drugs; 6. Patients whose urination diary (3 days before randomization) showed an average of >=8 times of urination every 24 hours; 7. Anticholinergic drugs should be discontinued for >=7 days prior to the screening period if no ß3 agonists or anticholinergic drugs are to be taken during the study period. Those who intend to continue taking beta-3 agonists or anticholinergics during the study period should keep the dosage unchanged until completion of the study; 8. Ability to communicate well with the investigator and willingness to comply with the whole test.
Exclusion criteria
Exclusion criteria: 1. Patients with cardiac pacemaker or implantable defibrillator (electrical stimulation affects pacemaker safety); 2. Patients with uncontrolled symptomatic urinary tract infection, bladder tumor and urinary tract calculi; 3. Patients with hydronephrosis combined with clinical symptoms of lumbar distension or lumbago on the corresponding side, and serum creatinine > 1.2 times the upper limit of normal value; 4. Patients with epilepsy, senile dementia, cerebral atrophy, acute stage of cerebrovascular disease, cognitive impairment, Parkinson's disease, complete spinal cord injury; 5. Psychiatric patients who can not cooperate with doctors; 6. Patients with skin lesions at the treatment site that cannot be stimulated ; 7. Patients with malignant tumor and other concomitant diseases seriously affect health; 8. Patients with grade III and higher pelvic organ prolapse; 9. Patients with other concomitant diseases that affect the efficacy of the trial; 10. Patients with residual urine volume >100 ml; 11. Patients who need to indwell the catheter or patients with intermittent catheterization to empty the bladder; 12. Pregnant patients, lactating patients, patients of childbearing age who plan to conceive or who have no safe contraceptives during the study period; 13. Patients who have participated in other clinical trials of drugs or devices within 1 months prior to enrollment; 14. Other circumstances that the investigators believe are inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of urination in average in 72 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of urinary urgency in average in 72 hours;Number of nocturnal urination in average in 72 hours;Urination volume per void in average in 72 hours;Average number of urinary incontinence in 72 hours;Overactive Bladder Symptom Score;Patient Perception of Bladder Condition Scale Score;American Urological Association Symptom Index Quality of Life Score;Evaluation of the usage performance of the device by the subjects; | — |
Countries
China
Contacts
Public ContactLiao Limin
China Rehabilitation Research Center, Beijing Bo'ai Hospital
Outcome results
None listed