OAB
Conditions
Interventions
Experimental group:implantable tibial nerve stimulators
Sponsors
Shanghai Pudong Gongli Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old, gender unlimited; 2) Suffering from overactive bladder or symptoms of overactive bladder, including persistent frequent urination, and/or urgency to urinate, and/or urge incontinence; 3) 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; 4) Anticholinergic drugs should be discontinued =7 days before the screening period if no anticholinergic drugs are to be taken during the study period.Those who intend to continue taking anticholinergic drugs during the study period should maintain their dosage and usage remained unchanged until the completion of the study core (3 months after stimulation) trial phase; 5) Be able to write urination diary and questionnaire regularly; 6) Informed and signed informed consent.
Exclusion criteria
Exclusion criteria: 1) The main disease is stress incontinence, defined as more than 1/3 of the incontinence is stress incontinence; 2) There is significant obstruction of the bladder outlet, defined as urine flow rate less than 15ml/min; 3) Women who are pregnant or breastfeeding, or have a family plan during the trial. 4) The patient has implanted a pacemaker, cardioverter defibrillator, or other electronic medical device (including sacral neuromodulation (SNM) devices); 5) Patients who failed to receive percutaneous tibial nerve stimulation; 6) accompanied by an uncured tumor; 7) Patients with pelvic organ prolapse of grade III and above; 8) Any signs of infection or inflammation at the implant site or incomplete skin; 9) Combined with urinary calculi or urinary system infection; 10) Pelvic surgery or lower urinary tract surgery within 3 months; 11) Situations in which other investigators consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of urination; | — |
Secondary
| Measure | Time frame |
|---|---|
| uroclepsia;Satisfaction; | — |
Countries
China
Contacts
Public ContactJianwei Lv
Shanghai Pudong Gongli Hospital
Outcome results
None listed