Neurogenic overactive bladder (nOAB) is a common and distressing sequela following stroke, significantly impairing quality of life and imposing a substantial financial burden. Existing pharmacological options often present adverse effects, while standard non-pharmacological treatments, such as pelvic floor muscle training (PFMT), face compliance and efficacy limitations in individuals with functional impairments. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique capable of modulating neuronal excitability and cortical plasticity. Targeting the supplementary motor area (SMA) via tDCS may regulate pelvic floor muscle (PFM) and detrusor activities. However, clinical evidence evaluating tDCS as an adjuvant to PFMT for stroke survivors with nOAB is lacking. This randomized controlled pilot trial aims to evaluate the feasibility, preliminary effectiveness, and cost-utility of active tDCS combined with PFMT compared to sham tDCS plus PFMT in stroke survivors suffering from nOAB.
Aged between 18-80 years with onset of stroke within one and twelve months of enrollment and having overactive bladder (OAB) symptoms;
Experiencing moderate (scoring 6-11 points on the Overactive Bladder Symptom Score [OABSS]) to severe OAB (scoring ≥ 12 points on OABSS);
Obtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
Presence of metallic implants in the cranium, intracardiac lines, increased intracranial pressure, cardiac pacemaker, cochlear implants, tumour, and skull abnormalities;
Family history of epilepsy/seizures;
Contraindications to transcranial magnetic stimulation.
Parallel
Active transcranial direct current stimulation (tDCS)
DeviceParticipants will receive active tDCS (1.5 mA for 20 minutes; current density 0.06 mA/cm²) 3 times per week for 8 weeks. tDCS will be conducted using two 5 x 7 cm² surface electrodes connected to a battery-powered stimulator (Neuroelectrics Instrument Controller, v 2.0). The anodal electrode will be placed over the supplementary motor area, and the cathodal electrode over the contralateral supraorbital region.
Sham transcranial direct current stimulation (tDCS)
DeviceParticipants will receive sham tDCS (active current for 30 seconds, then turned off) 3 times per week for 8 weeks. tDCS will be conducted using two 5 x 7 cm² surface electrodes connected to a battery-powered stimulator (Neuroelectrics Instrument Controller, v 2.0). The anodal electrode will be placed over the supplementary motor area, and the cathodal electrode over the contralateral supraorbital region.
Pelvic floor muscle training (PFMT)
BehavioralImmediately following tDCS, participants will receive supervised, individual (1:1) PFMT for 30 minutes per session, consisting of pelvic floor contraction exercises (contracting the urethra/shortening the penis and controlling passage of gas), each held for 10 seconds and followed by 10 seconds of relaxation. PFMT will be performed 3 times per week for 8 weeks.
Overactive bladder symptoms severity
Overactive bladder symptoms severity will be assessed using Overactive Bladder Symptom Score (OABSS). The total score of OABSS ranges from 0 to 15, with a higher score indicating higher symptom severity.
Recruitment Rate
Number of participants recruited and screened per week during the recruitment period. The unit of measure is participants/week.
Time to Complete Recruitment
Total time required to recruit the full study sample. The unit of measure is weeks.
Retention Rate
Percentage of enrolled participants who complete assessments at 8 weeks post-intervention, calculated as (number completing 8-week assessment / number enrolled) × 100. The unit of measure is %.
Adherence to Intervention
Percentage of total prescribed intervention sessions attended, calculated as (number of sessions attended / number of sessions prescribed) × 100. The unit of measure is %.
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