refractory overactive bladder
Conditions
Interventions
Control group: Stimulator implantation without sart-up and electrical stimulation treatment
Sponsors
China Rehabilitation Research Center, Beijing Boai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male and female patients, 18-75 years old; 2) Patients with overactive bladder (OAB) or patients with OAB symptoms; 3) Patients with the bladder diary showing an average of urination >=8 times in 24 hours during the 3-day screening period; 4) Patients with unsatisfactory results of anticholinergic drugs, or adverse reactions caused by anticholinergics, or patients unwilling to take long-term anticholinergic drugs, or patients who are sensitive to the side effects of anticholinergic drugs; 5) Patients who are not intended to continue to take anticholinergics during the study period are required to stop taking the anticholinergic drugs at least seven days before the screening period. For those planning to continue to take anticholinergic drugs during the research period, it is required to maintain the same usage and dosage until the end of the main study period; 6) Patients who voluntarily participate in this clinical study with signed written informed consent before the research.
Exclusion criteria
Exclusion criteria: 1) Patients who need to indwell the catheter or patients with intermittent catheterization to empty the bladder; 2) Patients with residual urine volume >100 ml; 3) Patients with mechanical bladder outlet obstruction; 4) Patients with stress urinary incontinence; 5) Patients with symptomatic urinary tract infections such as fever, hematuria, or pyuria; 6) Patients with bladder stones, ureteral stones or urethral stones; 7) Patients with known bladder or prostate cancer; 8) Patients with diabetes; 9) Patients who have accepted lower urinary tract endothelium such as botulinum toxin within 12 weeks before screening; 10) Pregnant women, lactating women, women of childbearing age who plan to conceive or who have no safe contraceptives during the study period; 11) Patients with a predicted survival of less than 1 year; 12) Patients with mental and cognitive impairments who are unable to cooperate with surgery and program control; 13) Patients with multiple system atrophy and complete spinal cord injury; 14) Patients who have participated in other clinical trials within 3 months before screening; 15) Other circumstances that the investigators believe are inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of 12 weeks after the treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average urinary urgency score per void;Urination times in 24 hours in average;Urination volume per void in average;Times of urinary incontinence ;OAB score;Changes in quality of life index score for 4 weeks, 12 weeks, 24 weeks and 48 weeks after the treatment, compared with the baseline;Assessments of the equipment performance by the researchers ;Evaluation of the usage performance of the implanted equipment and stimulator program controller by the intervention-group patients; | — |
Countries
China
Contacts
Public ContactLimin Liao
China Rehabilitation Research Center, Beijing Boai Hospital
Outcome results
None listed