Urgency Urinary Incontinence
Conditions
Interventions
Experimental group:Stimulator activation
Conrol group:Device deactivation during the initial 12-week period
Sponsors
Beijing Hospital
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, gender is not limited; 2. Patients with a definite diagnosis of refractory overactive bladder (i.e., patients with overactive bladder who have failed behavioral therapy, have not achieved expected efficacy or cannot tolerate adverse reactions to oral drugs after at least 6 weeks of treatment with M-receptor antagonists alone) and are accompanied by urge urinary incontinence, and the voiding diary records for 3 consecutive days during the screening period show that the number of urinary incontinence within 72 hours is >=4, and there is at least 1 urge urinary incontinence every 24 hours; 3. Normal upper urinary tract function and bladder capacity > 100 ml; 4. Have stopped using ß3 receptor agonists or anticholinergic drugs for the treatment of overactive bladder >=14 days before screening, or are taking the above drugs before screening and plan to continue taking them during the study and keep the dosage unchanged (after completing the core (12 weeks after randomization) trial phase, medication can be given or medication adjustment according to the needs of the condition as assessed by the investigator); 5. Able to communicate well with the investigator and willing to follow the requirements of the entire trial, follow the treatment restrictions specified in this protocol, and write a voiding diary and questionnaire in a standardized manner; 6. Volunteer to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of stress urinary incontinence; 2. Residual urine volume> 100 ml; 3. Presence of need for indwelling ureter or intermittent catheterization to empty the bladder; 4. Presence of grade III or higher pelvic organ prolapse; 5. Presence of urinary stones that can cause urinary urgency and frequent urination, recurrent episodes of symptomatic urinary tract infections or urinary tract infections (>=2 episodes within 6 months or >=4 episodes within 1 year), significant bladder outlet obstruction (maximum urinary flow rate 1.5 times the upper limit of normal value); 8. Mental illness, cognitive impairment, etc. who cannot cooperate with doctors; 9. Concomitant diseases that seriously affect health, such as malignant tumors or concomitant diseases that affect the efficacy of research/surgery, as judged by the investigator; 10. Bladder has been treated with botulinum toxin injection within 12 months before screening; 11. Female subjects of childbearing age who are pregnant, lactating, have a birth plan during the study, and do not agree to take medically recognized contraceptive measures (such as oral contraceptives, condoms, intrauterine devices, etc.) during the trial; 12. Those who have participated in or are participating in other interventional drug or medical device clinical trials within 3 months before screening; 13. Other situations that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week therapy response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean number of urinary urgency episodes;Mean number of nocturnal voids;Mean number of urgency urinary incontinence (UUI) episodes;OABSS;PPBC-S;N-QOL;Investigator-rated assessment of device handling;Subject-rated assessment of device performance; | — |
Countries
China
Contacts
Public ContactZhang Yaoguang
Beijing Hospital
Outcome results
None listed