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NCT Number: NCT07768137

Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurogenic Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, 999077, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Transcranial Direct Current Stimulation (tDCS)

Device

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.

Sham Transcranial Direct Current Stimulation (tDCS)

Device

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.

Pelvic Floor Muscle Training (PFMT)

Behavioral

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.

Primary outcomes

  1. Overactive bladder symptoms severity

    Time frame: 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 outcomes

  1. Recruitment Rate

    Time frame: 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.

  2. Time to Complete Recruitment

    Time frame: Through study completion, an average of 1 year.

    Total time required to recruit the full study sample. The unit of measure is weeks.

  3. Retention Rate

    Time frame: 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 %.

  4. Adherence to Intervention

    Time frame: 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 %.

  5. Adverse Events

    Time frame: Baseline to 8 weeks

    Number of participants in each group who experience adverse events, monitored throughout the intervention.

  6. Incontinence-related quality of life

    Time frame: Baseline and post-intervention at 8 weeks

    Incontinence-related quality of life will be assessed using the Incontinence Quality of Life Questonaire (I-QoL). The I-QoL score ranges from 0-100, with higher scores indicating higher quality of life.

  7. Detrusor Wall Thickness

    Time frame: 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).

  8. Bladder Neck Elevation

    Time frame: 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).

  9. Health-Related Quality of Life

    Time frame: 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.

  10. Healthcare Costs

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel KY Zheng, PhD

CONTACT

[email protected]

+852 53205956

Daniel KY Zheng, PhD

CONTACT

[email protected]

+852 53205956

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke: a Randomized Controlled Pilot Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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