1.Overactive bladder: mainly characterized by urinary urgency, often accompanied by frequent urination and nocturia, with or without urge incontinence, without other obvious pathological features such as urinary tract infection 2.Hypomobility, decreased bladder sensation
Conditions
Interventions
Closed-loop sacral nerve stimulation experimental group:On-demand sacral nerve stimulation based on perception of nerve signals from overactive bladder
Non-closed-loop sacral nerve stimulation control group:Sacral nerve stimulation system maintains continuous stimulation
Tibial nerve stimulation of the opening group:On-demand tibial nerve stimulation based on EEG signals
Tibial nerve stimulation sham opening group:Tibial nerve stimulation sham opening
Intravesical stimulation of the opening group:Closed-loop intravesical bladder stimulation based on electromyographic signals
Intravesical stimulation of the false opening group:False start-up in the IVES
Sponsors
Beijing Bo'ai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sacral nerve stimulation 1) Meet the diagnostic criteria for overactive bladder disease with or without bowel dysfunction in the 2019 edition of the Chinese Diagnostic and Therapeutic Guidelines for Urological and Men's Diseases; 2) Voluntarily participate in this clinical trial and sign an informed consent form; 3) Agree, after enrolment, that they will not arbitrarily add or subtract any medication related to lower urinary tract symptoms and pelvic and bowel function during the trial; 4) Be able to communicate well with the investigator and be willing to follow the entire trial requirements. Good communication and willing to follow the whole trial requirements. 2. Tibial nerve stimulation 1) Aged 18-75 years old, no gender limit; 2) Patients with overactive bladder (OAB) or symptoms of overactive bladder; 3) The 3-day voiding diary during the screening period shows an average of 24 hours of urination Patients who take =8 times; 4) Patients who are not satisfied with the effect of taking anticholinergic drugs, or cannot tolerate the adverse reactions caused by taking anticholinergic drugs, or are unwilling to take anticholinergic drugs for a long time, or have used anticholinergic drugs. Patients with contraindications to cholinergic drugs; 5) Those who do not plan to take anticholinergic drugs during the study period must have stopped taking anticholinergic drugs = 7 days before the screening period. If you plan to continue taking anticholinergic drugs during the study, you need to keep the usage and dosage unchanged until the study is completed; 6) Voluntarily participate in this clinical study, and the subject will sign a written informed consent before the start of the study. 3. Intravesical electrical stimulation 1) Aged =18 years old; 2) Patients who have been diagnosed with UAB and the duration of the disease is more than 3 months; 3) Those who voluntarily sign a written informed consent; 4) Can communicate well with researchers and Those who are willing to comply with the entire trial requirements.
Exclusion criteria
Exclusion criteria: 1. Sacral nerve stimulation 1) Pregnant and lactating women; 2) People with uncontrolled urinary tract infection, urinary tract obstruction, and urinary tract tumors; 3) People with mental illness who cannot cooperate with doctors; 4) People with non-urinary system diseases Malignant tumors and other concomitant diseases that seriously affect health; 5) Those who have received botulinum toxin treatment in the past 12 months; 6) Severe pelvic organ prolapse; 7) Those who have participated in other clinical trials 3 months before the trial; 8 ) Other circumstances in which the researcher deems it inappropriate to participate in the study. 2. Tibial nerve stimulation 1) Patients who need an indwelling urinary catheter or intermittent catheterization to empty the bladder; 2) Patients with residual urine volume >100ml; 3) Patients with mechanical bladder outlet obstruction; 4) Patients with stress urinary incontinence; 5) Patients with symptomatic urinary tract infection such as fever, hematuria, pyuria; 6) Patients with bladder stones, ureteral stones or urethral stones; 7) Patients with known bladder cancer or prostate cancer; 8) Patients with diabetes ; 9) Patients who have used lower urinary tract intracavitary treatment such as botulinum toxin within 12 weeks before screening; 10) Pregnant women, lactating women, women of childbearing age who plan to become pregnant during the study or who do not have safe contraceptive measures; 11) Expected survival period Patients less than 1 year old; 12) Patients with mental or cognitive impairment who are unable to cooperate with surgery and programming; 13) Patients with multiple system atrophy and complete spinal cord injury; 14) Those who have participated in other clinical trials within 3 months before screening; 15) Other circumstances in which the researcher deems it inappropriate to participate in the study. 3. Intravesical electrical stimulation 1) Patients with low bladder compliance (less than 20ml/cmH2O) during urodynamic examination; 2) Patients with mechanical obstruction of the outflow tract; 3) Patients with complete spinal cord injury; 4 ) Patients with uncured symptomatic urinary tract infection; 5) Patients with hydronephrosis or vesicoureteral reflux; 6) Patients with renal insufficiency (serum creatinine greater than 1.5 times the upper limit of normal); 7) Bladder and Patients with prostate malignant tumors; 8) Patients with pacemakers or defibrillators implanted in the body; 9) Patients with Alzheimer's disease, brain atrophy, acute phase of cerebrovascular disease, and cognitive impairment; 10) Epilepsy and mental illness cannot be combined with Physician collaborators; 11) Patients with positive preoperative infectious disease screening (hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and HIV antibody); 12) Pregnant women or patients preparing to become pregnant; 13) Participants in other medical institutions 3 months before the test Clinical trial participants; 14) Other circumstances in which the researcher deems it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturia;Overactive Bladder Symptom Score (OABSS) Scale;Residual urine volume;Change in voiding frequency from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency of bladder emptying;Wexner constipation score;Maximum urine flow rate;Software display automatically;The proportion of patients who were completely removed from intermittent catheterization;Frequency of intermittent catheterization;PPBC-S score;NBD score;Number of nocturnal urination;AUA-SI-QOL score;AUA-SI score;NBD-score;Wexner constipation score;Cleveland incontinence score;The incidence of adverse events;Average volume of urine output per session;Times of urgency to urinate;Number of urinary incontinence;PPBC-S;AUA-SI score;QOL score; | — |
Countries
China
Contacts
Public ContactLiao Limin
Beijing Bo'ai Hospital
Outcome results
None listed