N/A
N=61
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Urinary Incontinence, Urge
Bottom Line
View on ClinicalTrials.gov: NCT04652869 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study — 100; 90.4; 100 percentage of participants who completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial direct current stimulation (Device); Mindfulness (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Cynthia Conklin
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study |
100; 90.4; 100 | — |
| PRIMARY Acceptability of Study Procedures |
85.6; 83.4; 80.4 | — |
| PRIMARY Compliance With Study Procedures |
88.3; 84.1; 90.5; 94.4; 93.0 | — |
| PRIMARY Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues. |
-25; -35; -19 | — |
| PRIMARY Reaction Time to Urinary Stroop Task |
-36.95; -16.89; -81.63 | — |
| PRIMARY Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) |
-2.65; -2.36; -2.10 | — |
| PRIMARY Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention |
-0.81; -0.90; -0.95 | — |
Summary
Urge urinary incontinence (UUI) is a common problem in older women, which vastly reduces quality of life. UUI sufferers frequently report situational triggers (e.g. approaching the front door) leading to urinary urgency and/or leakage, which can be caused by psychological conditioning. This project will test the feasibility, acceptability, and efficacy of brief mindfulness (MI) and non-invasive brain stimulation (transcranial direct current stimulation; tDCS) to reduce reactivity to personal urgency cues and attenuate symptoms of UUI. This is a novel step towards providing personalized efficacious non-pharmacologic treatment for UUI.
Eligibility Criteria
Inclusion Criteria
- Female; 40+ years old
- Self-report situational urgency in at least 4 of 15 common scenarios
- At least 2 leaks/week
- Urge Urinary Incontinence symptomatology bother score ≥4
Exclusion Criteria
- Cognitive impairment (inability to complete tasks) as measured by Montreal Cognitive Assessment (MoCA) score 200ml)
- Interstitial cystitis
- Spinal cord injury
- Pelvic irradiation or other cause of pelvic nerve damage
- Active urinary tract infection (UTI)
Data sourced from ClinicalTrials.gov (NCT04652869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.