Stroke, Neurogenic Overactive Bladder
Conditions
Keywords
Transcranial direct current stimulation, Overactive bladder, Stroke
Brief summary
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.
Interventions
DEVICEActive transcranial direct current stimulation (tDCS)
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.
DEVICESham transcranial direct current stimulation (tDCS)
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.
BEHAVIORALPelvic floor muscle training (PFMT)
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The allocation of the participants will be sealed in an envelope, blinding the participants and assessors, and a third person (intervention implementer) will perform the blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive bladder symptoms severity | Baseline and post-intervention at 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Through study completion, an average of 1 year. | Number of participants recruited and screened per week during the recruitment period. The unit of measure is participants/week. |
| Time to Complete Recruitment | Through study completion, an average of 1 year. | Total time required to recruit the full study sample. The unit of measure is weeks. |
| Retention Rate | Baseline to 8 weeks | 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 | Baseline to 8 weeks | Percentage of total prescribed intervention sessions attended, calculated as (number of sessions attended / number of sessions prescribed) × 100. The unit of measure is %. |
| Adverse Events | Baseline to 8 weeks | Number of participants in each group who experience adverse events, monitored throughout the intervention. |
| Incontinence-related quality of life | Baseline and post-intervention at 8 weeks | 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. |
| Detrusor Wall Thickness | Baseline and post-intervention at 8 weeks | 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). |
| Bladder Neck Elevation | Baseline and post-intervention at 8 weeks | 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). |
| Health-Related Quality of Life | Baseline and post-intervention at 8 weeks | 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. |
| Healthcare Costs | Baseline and post-intervention at 8 weeks. | 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). |
Countries
China
Contacts
CONTACTDaniel KY Zheng, PhD
PRINCIPAL_INVESTIGATORPriya Kannan, PhD
The Hong Kong Polytechnic University
Outcome results
None listed