Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Phase: NA
Conditions: Urinary Incontinence, Urge
Sponsor: Cynthia Conklin

 
 
 
Mindfulness + tDCS to reduce urgency inconƟnence in women 
 
NCT# 04652869  
Study Protocol 9/13/2022 
 

Scientific background  
Urinary incontinence, particularly urinary urge incontinence (UUI), is a highly prevalent and 
costly ($83 billion/year) disorder among older women. Greater than 50% of UUI-related urgency 
and leakage may be due to situational incontinence provoked by confrontation with specific 
contextual triggers or cues (e.g., seeing one’s front/garage door, doing dishes). We recently 
found that women with UUI experience increased urgency and actual leakage when exposed to 
personal “urge” versus “safe” photographic cues taken from their daily lives. Decades of cue-
based research across other disorders has shown that such conditioned responses are rarely 
attenuated with pharmacologic methods and require cognitive and behavioral retraining. 
Therefore, new methods are needed to specifically target conditioned factors contributing to 
UUI, in order to effectively combat this persistent contributor to urgency and leakage and 
augment the efficacy of current UUI treatments. 
 
We propose to test two new intervention methods to attenuate UUI symptomatology and 
reactivity to urgency cues among women with situational UUI. These methods include brief 
mindfulness (MI) and transcranial direct current stimulation (tDCS). Employing our well-tested 
method to personalize cues, women with situational UUI will create photographic personal 
“urge” cues, which capture their strongest urgency, and “safe” cues, in which they do not 
experience urge. Then, we will examine the feasibility, acceptability, participant compliance, and 
efficacy of using MI and/or tDCS to reduce cue-provoked urgency and/or leakage to these 
salient personal cues, reduce reaction time on a urinary Stroop test, and decrease multiple UUI 
outcomes.  
 
Study Objectives:  
Aim 1: Assess intervention feasibility, acceptability, and compliance. H1: Feasibility: 
85% of all enrolled participants will complete the study, Acceptability: Moderate to high 
acceptability rating of ≥ 50 (0-100 scale) and Participant compliance: ≥ 75 (0-100 scale) for MI 
compliance on the self-reported post-study survey.  
Aim 2: Examine UUI symptom reduction. H1: Each intervention will lead to a pre-post 
and pre-follow-up reduction in number of UUI episodes, self-report urgency, and bladder symptom 
severity (ICIQ-FLUTS). H2: MI + tDCS will lead to the greatest reduction in these UUI symptoms.  
Aim 3: Examine attenuation of reactivity to urgency stimuli. H1: Each intervention will 
reduce cue-reactivity and urinary Stroop reaction time. H2: MI + tDCS will lead to greater 
reductions in these measures relative to either MI or tDCS alone.  
 
Study Design and methods  
We will examine the independent and combined effects of brief mindfulness (MI) and 
transcranial direct current stimulation (tDCS) across three group: 1) MI, 2) tDCS, 3) MI + tDCS. 
MI and / or tDCS will be employed during urgency-cue exposure to examine the efficacy of 
these methods to attenuate cue reactivity (cue-induced urgency, reaction time during a urinary 
Stroop test) and lead to reductions in self-reported bladder problem severity (ICIQ-FLUTS 
score), UUI episodes, and urgency ratings. Some participants will be trained in a brief 
mindfulness intervention (MI; 20-minute audio guide) to focus on body scan with acceptance 
language and will practice it out of session to use during cue exposure. Second, transcranial 
direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (dlPFC) with be 
used to increase cortical excitability in the dlPFC, aimed at increasing cognitive control when 
confronted with personal urgency cues. tDCS has been shown to reduce cue reactivity on its 
own, and we will also test it as such, but research has also shown augmentation of its 
effectiveness when paired with tasks that engage brain regions being targeted for related 
behavior change. Past research has shown that mindfulness engages the PFC and that women 
with UUI who are not responsive to pharmacotherapy demonstrate down regulation of the PFC, 

suggesting that tDCS combined with MI should further enhance cognitive control over reactivity 
to cue-provoked urgency and reduce UUI-related outcomes.  
 
Procedures and Protocols 
 
Sixty women will be recruited from the Pitt+Me online registry, local fliers and through 
collaboration with multiple community and university resources (see recruitment). Telephone 
screening will determine initial eligibility. Eligible participants will be invited to Dr. Conklin’s 
laboratory for informed consent, further screening, and a semi-structured interview to identify 
personal urgency and safe cue environments, of which each participant will take pictures. 
Participants will then be randomized to one of 3 groups: 1) Mindfulness, 2) tDCS, 3) 
Mindfulness + tDCS. We will use the SAS® high quality pseudorandom deviate generator (SAS 
Institute, Cary, NC) to randomize subjects in a 1:1:1 ratio. We will use a blocked randomization 
scheme to force an approximate balance between the number of subjects in each arm at any 
point during recruitment. Participants will undergo 4 urgency cue exposure sessions with their 
assigned intervention. Cue-induced urgency and reaction time to modified Stroop will be 
assessed at baseline and post-training. Bladder diary and urgency survey will be completed 
daily throughout the study, and for one-week post-training.  
 
Interventions:  
1) Brief Mindfulness (Body Scan with awareness/acceptance language): Imaging 
studies have revealed enhanced activation of the PFC1, and more specifically the dlPFC2,3, 
during mindfulness practice, and while completing executive processing tasks after MI training. 
During mindfulness training, practitioners cultivate a nonjudgmental state of attention to 
experiences in the present moment4, resulting in active engagement of attentional control 
abilities5-7. Recent work on MI-based stress reduction (MBSR) to attenuate UUI symptoms 
found significant reductions in UUI episodes post-treatment, with continued reduction over 6 
months post-treatment, suggesting increased benefit over time8,9. Mindfulness has also been 
shown to reduce cue reactivity, with significant reductions in cue responding to food10, anxiety11, 
addiction12-14, and mood regulation15 cues following MI training, presumed to reflect increased 
cognitive control over salient disorder-related stimuli. Recently, less intensive brief mindfulness 
interventions (i.e., significantly less than 8-week MBSR) have been tested with positive 
results.16-20 This work has shown immediate beneficial effects on anxiety18, coping with social 
stressors3, acute pain20 and increasing self-control,19 without requiring a full MBSR program21. 
Brief interventions are lower cost, less burdensome and more accessible at home, which is 
attractive for a self-management care model for chronic illness.22,23 Given the success in 
reducing UUI episodes following the full 8-week MBSR program8,9 UUI is a particularly good 
candidate for testing new brief mindfulness methods.  
A component of MBSR commonly isolated for brief intervention is body scan24. This 
method involves focused attention on the present moment through observing one’s breath and 
bodily sensations, while becoming aware of, and accepting without judgement, any thoughts 
and feelings that arise.25 Body scans are used for brief mindfulness training in both clinical and 
research protocols, and typically last between 5 and 30 min20,21. We will test a novel MI 
presented and practiced with a 15-minute guided audio recording consisting of guidance to 
attend to physical sensations with a gentle, accepting attitude.  
2) Transcranial Direct Current Stimulation (tDCS): tDCS is a safe, non-invasive 
method of brain stimulation that can enhance cortical excitability and help attenuate cue-
induced reactivity. tDCS has become increasingly popular in clinical and neurocognitive 
research, showing promising efficacy for targeting cue-reactivity to stimuli related to a number of 
disorders (depression, addiction, anxiety), assisting physical and cognitive recovery secondary 
to stroke and spinal cord injury26-28, and promoting cognitive enhancement in healthy subjects.29-

32 Addiction research incorporating tDCS has shown reductions in cue-induced craving in 
response to drug-related stimuli from baseline to re-test following a single session of tDCS,33 as 
well as reductions in cue-induced craving and actual smoking after 3-5 tDCS sessions.34  
In anxiety research, reductions in self-reported and physiological reactivity to fear stimuli 
have been noted after similar tDCS methods35. These effects have been characterized through 
consideration of the PFC’s role in decision-making and cognitive control and are presumed to 
reflect increased control over cue reactivity  following PFC-targeted tDCS  Although effective as 
a standalone treatment to reduce reactivity, the effects of tDCS are greatly enhanced when 
stimulation is paired with behavioral training that engages the brain processes that underlie the 
targeted behavior.36 Thus, we purport that brief mindfulness during urgency-cue exposure is a 
prime candidate for augmentation with dlPFC-targeted tDCS. Enhancement of excitability in the 
PFC during mindfulness, which has also been shown to increase dlPFC activation3,37,38 and 
cognitive control39 should lead to greater ability to dynamically recruit cognitive control systems 
during urgency situations, which will aid in retraining the salience of urgency-related cues. 
 
Inclusion Criteria: 
• Ambulatory women aged 40+ years 
• Able to differentiate between stress symptoms (cough, laugh, exercise) and urgency 
symptoms (leakage following sudden strong urge to void that is difficult to defer), and history 
suggestive of UUI using our detailed incontinence history questionnaires and clinical expertise. 
• self-report of 2 leaks/week, 
• Self-report of ‘sometimes’ or ‘often’ experiencing urgency or leakage in at least 4 of 15 
common urgency trigger scenarios 
• A bother score ≥4 on a situational urgency questionnaire 
• Subjects using OAB medication will be considered if they have used it consistently for 3 
months and plan to keep using it throughout the duration of the study. 
 
Exclusion criteria: 
• Inability to reliably describe incontinence type (i.e. Inability to identify situational urgency 
trigger scenarios, differentiate between stress and urgency incontinence, describe leakage 
scenarios.) 
• Cognitive impairment (inability to: accurately complete a bladder diary, identify and take 
appropriate photos of urge cue and safe cue scenarios, appropriately give incontinence history) 
• Spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer 
• Urinary retention [PVR >200 ml] 
• Interstitial cystitis; artificial sphincter implant 
• Medical instability or expected change in medication during the study (e.g. change in 
anticholinergic, diuretic medication) 
• Conditions that preclude tDCS including: Epilepsy or current seizure disorder, pregnant or 
lactating, implanted cardiac or brain medical device. 
 
Primary Outcomes: Data Analysis Plan. Prior to hypothesis testing, descriptive statistics and 
graphic displays will be used to identify outliers, missing data, and patterns of attrition, and to 
guide transformations and appropriate tests. The primary analyses will be evaluated via mixed 
model regressions with Bonferroni post-hoc comparisons. Mixed model regression features 
advantages over traditional regression due to the ability to handle repeated assessments of both 
predictor variables and outcome variables. For Aim 1, We will assess feasibility as >85% study 

completion, acceptability as a score ≥50 on 8-item post-study survey rating (scale 0-100), and 
mindfulness compliance as an average rating ≥75 on the compliance survey (scale 0-100). We 
will use chi-square to assess attrition differences between groups, and one-way ANOVA to assess 
differences in acceptability and compliance ratings. For Aim 2, mixed model regressions will test 
the main effects of experimental group (1=MI, 2=tDCS, and 3=MI+tDCS) on ICIQ-FLUTS score 
(pre, post, and follow-up), UUI episodes, and urgency survey scores (3-day mean score at 
baseline, last three days before re-test, and last 3-days of follow-up) as dependent variables. Pre-
intervention (baseline) levels of each dependent variable will be entered as a covariate in 
respective regression models. This process will be repeated for Aim 3, with separate models 
evaluating treatment effects on Stroop RT and cue-provoked urgency. For Stroop RT, the primary 
dependent variable will be post-test minus pre-test change. For cue-provoked urgency, the 
primary dependent variable will represent a double-difference score of urgency minus safe cues, 
and post-test minus test.  
 
 
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