BCIwiki (bciwiki.com) — A clinical study of closed-loop collaborative regulation based on a brain-computer interface for the treatment of female overactive bladder has been registered with the Chinese Clinical Trial Registry (ChiCTR) under ID ChiCTR2600126047, with a registration date of June 2, 2026 and a recruitment status of not yet recruiting. The primary sponsor is The First Affiliated Hospital of Soochow University.
The trial is an interventional, parallel-design study that plans to enroll 66 women aged 18 to 75, with 33 in the experimental group and 33 in the control group. The experimental group receives BCI-based fNIRS-rTMS closed-loop neuromodulation, while the control group receives sham closed-loop (open-loop) rTMS neuromodulation. The primary outcome is the overactive bladder symptom score (OABSS). Secondary outcomes include a treatment satisfaction visual analogue scale score, neurophysiological metrics, the proportion of participants with at least a 3-point improvement in OABSS, adverse events, the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form, 24-hour voiding frequency, 24-hour urgency episodes, 24-hour urgency urinary incontinence episodes and 24-hour nocturnal voids.
Eligible participants must meet the International Continence Society (ICS) diagnostic criteria for overactive bladder, have symptoms lasting at least 3 months, and score at least 3 points on the OABSS with at least 2 points on the urgency item; a healthy control group is also included. Exclusion criteria include pregnancy or breastfeeding, stress-predominant mixed urinary incontinence, indwelling catheterization or elevated post-void residual urine volume, symptomatic urinary tract infection, a history of neurogenic bladder, botulinum toxin injection within the past 6 months, and an implanted sacral neuromodulation device.
Funding comes from the Suzhou Municipal Health Commission Key Project for Strengthening Science, Education and Healthcare. The registration record was last updated on June 8, 2026. The registration page contains only bibliographic and design fields and does not disclose device models, actual enrollment numbers or any results.