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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Participants 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.
Participants 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.
Immediately 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.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China
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.
Time frame: Baseline and post-intervention at 8 weeks
Recruitment Rate
Number of participants recruited and screened per week during the recruitment period. The unit of measure is participants/week.
Time frame: Through study completion, an average of 1 year.
Time to Complete Recruitment
Total time required to recruit the full study sample. The unit of measure is weeks.
Time frame: Through study completion, an average of 1 year.
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 %.
Time frame: Baseline to 8 weeks
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 %.
Time frame: Baseline to 8 weeks
Adverse Events
Number of participants in each group who experience adverse events, monitored throughout the intervention.
Time frame: Baseline to 8 weeks
Incontinence-related quality of life
Incontinence-related quality of life will be assessed using the Incontinence Quality of Life Questionnaire (I-QoL). The I-QoL score ranges from 0-100, with higher scores indicating higher quality of life.
Time frame: Baseline and post-intervention at 8 weeks
Detrusor Wall Thickness
Detrusor wall thickness measured using the Mindray Consona N9 ultrasound system (Sonos Medical Limited) with a convex transducer of 3-6 MHz. An increase in detrusor wall thickness indicates detrusor overactivity. The unit of measure is millimeter (mm).
Time frame: Baseline and post-intervention at 8 weeks
Bladder Neck Elevation
Bladder neck elevation, a surrogate measure of pelvic floor muscle strength, will be measured using the Mindray Consona N9 ultrasound system (Sonos Medical Limited). Greater bladder neck elevation indicates stronger pelvic floor muscle strength. The unit of measure is millimeter (mm).
Time frame: Baseline and post-intervention at 8 weeks
Health-Related Quality of Life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The score ranges from -0.864 to 1.0, where 1.0 indicates full health and higher scores indicate better health-related quality of life.
Time frame: Baseline and post-intervention at 8 weeks
Healthcare Costs
Healthcare Costs will be collected using the Client Service Receipt Inventory (CSRI) to calculate total healthcare-related costs per participant from both healthcare provider and societal perspectives. The unit of measure is Hong Kong Dollars (HKD).
Time frame: Baseline and post-intervention at 8 weeks.
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