Mindfulness + tDCS to Reduce Urgency Incontinence in Women

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Urge
• Intervention / Treatment: Behavioral: Mindfulness; Device: Transcranial direct current stimulation

Detailed Description

Urinary urgency incontinence (UUI) is a highly prevalent, morbid and costly (up to $83 billion/year) disorder among older women, with up to 36% of those over 65 afflicted. One commonly experienced phenomenon among those with UUI is conditioned bladder responses to external triggers, often labeled "situational incontinence." Situational incontinence is described by sufferers as urinary urgency and leakage when confronted with specific contextual triggers or cues, such as approaching the front/garage door 'latch-key incontinence', and exposure to running water such as doing dishes. Generally ascribed to 'bladder spasms' (detrusor overactivity), studies have revealed that anywhere between 42% and 80% of women with UUI experience situationally provoked urgency, with approximately 26% of those experiencing situationally triggered leakage. The researchers recent work has focused on developing methods to recreate exposure to individuals' situational urgency cues, testing the impact of "urgency" and "safe" cues on self-report urgency and actual leakage, and finally assessing the role of bladder control mechanisms in the brain in response to these personal situational cues. The researchers found that women with situational UUI experienced increased urgency and leakage when exposed to personal "urgency" versus "safe" photographic cues from their daily lives. Further, brain areas related to attentional and visuospatial processing were activated during exposure to urge, but not safe, cues. Past studies of urgency simulated by bladder filling, show that prefrontal cortex, a seat of executive control, is activated to aid in controlling bladder activation. However, the study found that the PFC was not recruited during exposure to visual cues among women with situational urgency. Thus, the researchers propose that interventions capable of enhancing PFC activation during exposure to urgency situations should enable women to gain executive control over cues and result in less cue-provoked urgency and leakage, as well as overall UUI symptomatology. Using these now well-tested methods to personalize stimuli with photographs of urgency-provoking situational cues, the goal is to test the feasibility, acceptability, and compliance of these promising methods to attenuate urgency-related reactivity and reduce UUI symptoms. These novel methods include: (1) Brief mindfulness (MI) focused on body scan and acceptance language, (2) Transcranial direct current stimulation (tDCS) applied to the dorsolateral PFC, and (3) a combination of MI + tDCS. Sixty women with situational UUI will be randomized into a 7-session study, with a mail-in follow up 1-week post-training. All participants will undergo 4 urgency-cue exposure training sessions during which they will engage in one of the three interventions, based on group. Changes in urgency will be assessed via pre-post training differences in: Cue-reactivity to personal urge and safe cues, reaction time to a urinary Stroop task, self-report severity of bladder problems, and UUI episodes and urgency ratings on a daily bladder diary. Attenuating reactivity to situational urgency cues will increase our ability to complement and enhance the efficacy of UUI therapy and reduce symptom burden for its many sufferers.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 an MoCA < 26
• Urinary retention (PVR>200ml)
• Interstitial cystitis
• Spinal cord injury
• Pelvic irradiation or other cause of pelvic nerve damage
• Active urinary tract infection (UTI)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Training; Mindfulness training	Behavioral: Mindfulness; Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.
Experimental: Transcranial Direct Current Stimulation (tDCS); Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Device: Transcranial direct current stimulation; Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex; Other Names: tDCS
Experimental: Mindfulness + tDCS; Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Behavioral: Mindfulness; Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.; Device: Transcranial direct current stimulation; Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of study procedures measured by percentage of enrolled participants who complete the study		4-weeks
Acceptability of study procedures measured by 8-item with a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability.		4-weeks
Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance		4-weeks
Change from baseline in cue-induced reactivity to personal photographic urge cues as measured by a 8-item 0-100 scale questionnaire. A higher score indicates greater cue-reactivity		Baseline to 1 week
Reaction time to Urinary Stroop Task	Change in reaction time to words associated with urgency	Baseline to 1 week
Change from baseline in severity of bladder problem measured by the ICIQ-FLUTS a 12-item questionnaire evaluating urinary tract symptoms and impact on quality of life. A higher score indicates greater symptoms and greater impact on quality of life.		Baseline to 1 week
Urge Urinary Incontinence (UUI) Incidence	Change in the number of UUI Incidences	Baseline to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Change	Treatment change will be examined by plotting the slope and linearity of daily bladder diary and urgency survey data	4 weeks
Individual Differences as measured by age, years of UUI and baseline measures as moderators of the efficacy of the intervention		4 weeks

Collaborators and Investigators

• Sponsor: Cynthia Conklin
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Transcranial Direct Current Stimulation (tDCS); Situational Urge Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
• Other Study ID Numbers: STUDY19110132; 1R21AG064361 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
• IPD Sharing Time Frame: Following publication, no end date
• IPD Sharing Access Criteria: Any purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes