StrokeNCT07768137
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
A study testing Active transcranial direct current stimulation (tDCS) and Pelvic floor muscle training (PFMT) in people with Stroke and Neurogenic Overactive Bladder, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Neurogenic Overactive Bladder
- What is being tested?
- Active transcranial direct current stimulation (tDCS) and Pelvic floor muscle training (PFMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-80 years; (2) having overactive bladder (OAB) symptoms (such as urgency, urine leakage, frequent urination, or frequent night-time urination) after stroke; (3) experiencing moderate (scoring 6-11 points on the Overactive Bladder Symptom Score [OABSS]) to severe OAB (scoring ≥ 12 points on OABSS); and (4) obtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
Who cannot join
- a personal or family history of epilepsy or seizures; (2) metallic implants or implanted electronic devices in or near the head, including cochlear implants, intracranial shunts, deep brain stimulation electrodes, surgical clips, staples, or other cranial metallic implants; (3) a cardiac pacemaker or other implanted electronic medical device; (4) increased intracranial pressure, an intracranial tumour, skull abnormalities, previous significant brain injury, or previous brain surgery; (5) skin lesions, infection, broken skin, or marked skin sensitivity at the electrode-placement sites; (6) frequent or severe headaches; (7) serious or unstable medical conditions, or use of medications that may affect brain excitability; (8) a history of substantial alcohol or substance misuse; (9) pregnancy or possible pregnancy; or (10) have received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke: a Randomized Controlled Pilot Trial
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.
- Conditions
- Stroke, Neurogenic Overactive Bladder
- Being tested
- Active transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS), Pelvic floor muscle training (PFMT)
- Keywords
- Transcranial direct current stimulation, Overactive bladder, Stroke
- Medical subject headings
- Stroke, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) | Experimental | Not described Receives: Device: Active transcranial direct current stimulation (tDCS); Behavioral: Pelvic floor muscle training (PFMT) |
| Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Pelvic floor muscle training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention at 8 weeks
Secondary outcomes (10)
Recruitment Rate
Number of participants recruited and screened per week during the recruitment period. The unit of measure is participants/week.
Measured: 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.
Measured: 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 %.
Measured: 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 %.
Measured: Baseline to 8 weeks
Adverse Events
Number of participants in each group who experience adverse events, monitored throughout the intervention.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline and post-intervention at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start10 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Priya Kannan, The Hong Kong Polytechnic University
- Investigators
- Priya Kannan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768137
- Sponsor's protocol ID
- HSEARS20260724022
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Because the IPD will contain sensitive privacy data of the participants, it will not be suitable to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07768137
- Acronym / sponsor ID
- HSEARS20260724022
- Conditions
- Stroke, Neurogenic Overactive Bladder
- Keywords
- Transcranial direct current stimulation, Overactive bladder, Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) | Experimental | Device: Active transcranial direct current stimulation (tDCS), Behavioral: Pelvic floor muscle training (PFMT) |
| Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) | Sham comparator | Device: Sham transcranial direct current stimulation (tDCS), Behavioral: Pelvic floor muscle training (PFMT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged between 18-80 years; (2) having overactive bladder (OAB) symptoms (such as urgency, urine leakage, frequent urination, or frequent night-time urination) after stroke; (3) experiencing moderate (scoring 6-11 points on the Overactive Bladder Symptom Score [OABSS]) to severe OAB (scoring ≥ 12 points on OABSS); and (4) obtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
Key exclusion criteria (1 listed)
- a personal or family history of epilepsy or seizures; (2) metallic implants or implanted electronic devices in or near the head, including cochlear implants, intracranial shunts, deep brain stimulation electrodes, surgical clips, staples, or other cranial metallic implants; (3) a cardiac pacemaker or other implanted electronic medical device; (4) increased intracranial pressure, an intracranial tumour, skull abnormalities, previous significant brain injury, or previous brain surgery; (5) skin lesions, infection, broken skin, or marked skin sensitivity at the electrode-placement sites; (6) frequent or severe headaches; (7) serious or unstable medical conditions, or use of medications that may affect brain excitability; (8) a history of substantial alcohol or substance misuse; (9) pregnancy or possible pregnancy; or (10) have received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active 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. | Device | Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) |
| Sham 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. | Device | Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) |
| Pelvic 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. | Behavioural | Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT), Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT) |
Primary outcome
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.
10 secondary outcomes
Recruitment Rate
Time frame: Through study completion, an average of 1 year.
Time to Complete Recruitment
Time frame: Through study completion, an average of 1 year.
Retention Rate
Time frame: Baseline to 8 weeks
Adherence to Intervention
Time frame: Baseline to 8 weeks
Adverse Events
Time frame: Baseline to 8 weeks
Incontinence-related quality of life
Time frame: Baseline and post-intervention at 8 weeks
Detrusor Wall Thickness
Time frame: Baseline and post-intervention at 8 weeks
Bladder Neck Elevation
Time frame: Baseline and post-intervention at 8 weeks
Health-Related Quality of Life
Time frame: Baseline and post-intervention at 8 weeks
Healthcare Costs
Time frame: Baseline and post-intervention at 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Because the IPD will contain sensitive privacy data of the participants, it will not be suitable to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priya Kannan, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation (tDCS) and Pelvic floor muscle training (PFMT) in people with Stroke and Neurogenic Overactive Bladder, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel KY Zheng, PhD (+852 53205956, daniel.zheng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive bladder symptoms severity (time frame: Baseline and post-intervention at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.