Female overactive bladder, OAB
Conditions
Interventions
experiment group:BCI-Based fNIRS-rTMS Closed-Loop Neuromodulation
control group:Sham-Closed-Loop (Open-Loop) rTMS Neuromodulation
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. OAB Patient Group: Female patients meeting the International Continence Society (ICS) diagnostic criteria for OAB will be recruited. Inclusion Criteria: (1) Female patients meeting the ICS diagnostic criteria for OAB (urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, and in the absence of urinary tract infection or other obvious pathological changes); (2) Meeting any of the following standards: 1) Wet OAB: Average voiding frequency >= 8 times/day and daily urgency urinary incontinence episodes >= 1 time/day; 2) Dry OAB: Average voiding frequency >= 8 times/day, average urgency episodes >= 3 times/day, and daily urgency urinary incontinence episodes = 3 months; (5) Overactive Bladder Symptom Score (OABSS) >= 3 points, with the urgency item score >= 2 points. 2. Healthy Control Group: Additionally, healthy controls must meet the following inclusion criteria: (1) A 3-day bladder diary showing no abnormalities; (2) Absence of lower urinary tract symptoms such as frequency, urgency, or incontinence.
Exclusion criteria
Exclusion criteria: 1. Women who are breastfeeding, pregnant, or planning to become pregnant during the study period; or women of childbearing potential who are not using highly reliable contraception; 2. Women with significant stress urinary incontinence or mixed urinary incontinence predominantly characterized by stress incontinence; 3. Women requiring indwelling catheterization, performing intermittent self-catheterization, or presenting with elevated post-void residual urine volume (e.g., >150 mL); 4. Women with symptomatic urinary tract infections, chronic inflammatory conditions (such as interstitial cystitis), or bladder stones; 5. Women with an average total daily urine output >3000 mL during the 3-day bladder diary period; 6. Patients with a history of neurogenic bladder, bladder pain syndrome, urological/pelvic malignancies, or prior pelvic radiation therapy; 7. Subjects taking medications that may affect bladder function (e.g., diuretics); or patients who have received botulinum toxin injections within the past 6 months; 8. Patients with an implanted sacral neuromodulation device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overactive bladder symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Satisfaction Visual Analogue Scale Score;Neurophysiological Metrics;Proportion of participants with a =3-point improvement in OABSS score (response rate);Adverse Event(s);International Consultation on Inocontinence Questionnaire - Urinary Inocontinence Short Form;24-hour voiding frequency, the number of 24-hour urgency episodes, 24-hour urgency urinary incontinence (UUI) episodes, and 24-hour nocturnal voids (nocturia);Global Impression of Severity;Score of Patient Perception of Bladder Condition;Patient Global Impression of Improvement; | — |
Countries
China
Contacts
Public ContactZhu Hongjun
The First Affiliated Hospital of Soochow University
Outcome results
None listed