ClinicalTrials.gg
Not yet recruitingNCT07768137Updated Oct 26, 2026

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

An interventional study of Active transcranial direct current stimulation (tDCS) and Sham transcranial direct current stimulation (tDCS) in Stroke and Neurogenic Overactive Bladder, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Updated Oct 26, 2026Start date movedEligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Neurogenic Overactive Bladder

Keywords

  • Transcranial direct current stimulation
  • Overactive bladder
  • Stroke
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

(1) 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 (MMSE) score of ≥ 24.

Exclusion criteria

Exclusion Criteria:

(1) 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)

    Device: Active transcranial direct current stimulation (tDCS) · Behavioral: Pelvic floor muscle training (PFMT)

  • Sham comparator
    Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)

    Device: Sham transcranial direct current stimulation (tDCS) · Behavioral: Pelvic floor muscle training (PFMT)

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. Adverse Events

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

    Time frame: Baseline to 8 weeks

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Because the IPD will contain sensitive privacy data of the participants, it will not be suitable to be shared.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 14, 2026→Nov 10, 2026
Oct 26, 2026
Eligibility
1 inclusion criterion edited, 2 removed; 1 exclusion criterion added, 3 removed
What changed in the criteria
Inclusion criteria
  • RemovedAged between 18-80 years with onset of stroke within one and twelve months of enrollment and having overactive bladder (OAB) symptoms;
  • EditedExperiencingAged 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.
  • RemovedObtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
Exclusion criteria
  • RemovedPresence of metallic implants in the cranium, intracardiac lines, increased intracranial pressure, cardiac pacemaker, cochlear implants, tumour, and skull abnormalities;
  • RemovedFamily history of epilepsy/seizures;
  • RemovedContraindications to transcranial magnetic stimulation.
  • Addeda 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.
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Start date Sep 14, 2026→Nov 10, 2026
    Eligibility 1 inclusion criterion edited, 2 removed; 1 exclusion criterion added, 3 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedAged between 18-80 years with onset of stroke within one and twelve months of enrollment and having overactive bladder (OAB) symptoms;
    • EditedExperiencingAged 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.
    • RemovedObtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
    Exclusion criteria
    • RemovedPresence of metallic implants in the cranium, intracardiac lines, increased intracranial pressure, cardiac pacemaker, cochlear implants, tumour, and skull abnormalities;
    • RemovedFamily history of epilepsy/seizures;
    • RemovedContraindications to transcranial magnetic stimulation.
    • Addeda 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.
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07768137
Responsible party
Dr. Priya Kannan (Associate Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Aug 17, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Daniel KY Zheng, PhD
Contact
daniel.zheng@polyu.edu.hk
+852 53205956
Daniel KY Zheng, PhD
Contact
kangyong.zheng@connect.polyu.hk
+852 53205956
Priya Kannan, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion