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

19 augustus 2026 bijgewerkt door: Dr. Priya Kannan, The Hong Kong Polytechnic University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 999077
        • The Hong Kong Polytechnic University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
Apparaat: 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.
Gedragsmatig: 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.
Sham-vergelijker: Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
Gedragsmatig: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overactive bladder symptoms severity
Tijdsspanne: 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.
Baseline and post-intervention at 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment Rate
Tijdsspanne: 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.
Through study completion, an average of 1 year.
Time to Complete Recruitment
Tijdsspanne: Through study completion, an average of 1 year.
Total time required to recruit the full study sample. The unit of measure is weeks.
Through study completion, an average of 1 year.
Retention Rate
Tijdsspanne: 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 %.
Baseline to 8 weeks
Adherence to Intervention
Tijdsspanne: 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 %.
Baseline to 8 weeks
Adverse Events
Tijdsspanne: Baseline to 8 weeks
Number of participants in each group who experience adverse events, monitored throughout the intervention.
Baseline to 8 weeks
Detrusor Wall Thickness
Tijdsspanne: 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).
Baseline and post-intervention at 8 weeks
Bladder Neck Elevation
Tijdsspanne: 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).
Baseline and post-intervention at 8 weeks
Health-Related Quality of Life
Tijdsspanne: 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.
Baseline and post-intervention at 8 weeks
Healthcare Costs
Tijdsspanne: 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).
Baseline and post-intervention at 8 weeks.
Incontinence-related quality of life
Tijdsspanne: 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.
Baseline and post-intervention at 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hong Kong Polytechnic University

Onderzoekers

  • Hoofdonderzoeker: Priya Kannan, PhD, The Hong Kong Polytechnic University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

14 september 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

2 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2026

Eerst geplaatst (Werkelijk)

17 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HSEARS20260727002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Because the IPD will contain sensitive privacy data of the participants, it will not be suitable to be shared.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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