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Mindfulness + tDCS to Reduce Urgency Incontinence in Women

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652869


Contacts
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Contact: Cynthia Conklin, PhD 412-586-9840 conklinca@upmc.edu
Contact: Becky Clarkson, PhD 412-647-1270 bdc29@pitt.edu

Locations
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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
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Principal Investigator: Cynthia Conklin, PhD University of Pittsburgh
Principal Investigator: Becky Clarkson, PhD University of Pittsburgh
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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    Key Record Dates
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

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