Mindfulness + tDCS to Reduce Urgency Incontinence in Women

• ClinicalTrials.gov Identifier: NCT04652869
• Recruitment Status: Not yet recruiting
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Sponsor: Cynthia Conklin
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Cynthia Conklin, University of Pittsburgh

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence, Urge	Device: Transcranial direct current stimulation; Behavioral: Mindfulness	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mindfulness + tDCS to Reduce Urgency Incontinence in Women
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: October 2022

Arms and Interventions

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 Name: tDCS
Experimental: Mindfulness + tDCS; Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Device: Transcranial direct current stimulation; Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex; Other Name: tDCS; 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of study procedures measured by percentage of enrolled participants who complete the study [ Time Frame: 4-weeks ]
2. Acceptability of study procedures measured by 8-item with a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability. [ Time Frame: 4-weeks ]
3. Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance [ Time Frame: 4-weeks ]
4. 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 [ Time Frame: Baseline to 1 week ]
5. Reaction time to Urinary Stroop Task [ Time Frame: Baseline to 1 week ]
   Change in reaction time to words associated with urgency
6. 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. [ Time Frame: Baseline to 1 week ]
7. Urge Urinary Incontinence (UUI) Incidence [ Time Frame: Baseline to 1 week ]
   Change in the number of UUI Incidences

Secondary Outcome Measures :

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

Eligibility Criteria

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

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 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)

Contacts and Locations

Contacts

Contact: Cynthia Conklin, PhD; 412-586-9840; conklinca@upmc.edu

Contact: Becky Clarkson, PhD; 412-647-1270; bdc29@pitt.edu

Locations

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Contact: Cynthia Conklin, PhD 412-586-9840 conklinca@upmc.edu

Contact: Becky Clarkson, PhD 412-647-1270 bdc29@pitt.edu

Principal Investigator: Cynthia Conklin, PhD

Principal Investigator: Becky Clarkson, PhD

Sub-Investigator: Carol Greco, PhD

Sub-Investigator: Brian Coffman, PhD

Sub-Investigator: Shachi Tyagi, MD

Sponsors and Collaborators

Cynthia Conklin

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Cynthia Conklin, PhD; University of Pittsburgh
• Principal Investigator: Becky Clarkson, PhD; University of Pittsburgh

More Information

• Responsible Party: Cynthia Conklin, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04652869
• Other Study ID Numbers: STUDY19110132; 1R21AG064361 ( U.S. NIH Grant/Contract )
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Following publication, no end date
• Access Criteria: Any purpose

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Cynthia Conklin, University of Pittsburgh:

Transcranial Direct Current Stimulation (tDCS); Mindfulness; Situational Urge Urinary Incontinence

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders