Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Primary Purpose
Urinary Incontinence, Urge
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Transcranial Direct Current Stimulation (tDCS), Mindfulness, Situational Urge Urinary Incontinence
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 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)
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Mindfulness Training
Transcranial Direct Current Stimulation (tDCS)
Mindfulness + tDCS
Arm Description
Mindfulness training
Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Outcomes
Primary Outcome Measures
Feasibility of study procedures measured by percentage of enrolled participants who complete the study
Acceptability of study procedures measured by 8-item with a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability.
Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance
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
Reaction time to Urinary Stroop Task
Change in reaction time to words associated with urgency
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.
Urge Urinary Incontinence (UUI) Incidence
Change in the number of UUI Incidences
Secondary Outcome Measures
Treatment Change
Treatment change will be examined by plotting the slope and linearity of daily bladder diary and urgency survey data
Individual Differences as measured by age, years of UUI and baseline measures as moderators of the efficacy of the intervention
Full Information
NCT ID
NCT04652869
First Posted
November 25, 2020
Last Updated
February 15, 2023
Sponsor
Cynthia Conklin
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04652869
Brief Title
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Official Title
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cynthia Conklin
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
Transcranial Direct Current Stimulation (tDCS), Mindfulness, Situational Urge Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Description
Mindfulness training
Arm Title
Transcranial Direct Current Stimulation (tDCS)
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Arm Title
Mindfulness + tDCS
Arm Type
Experimental
Arm Description
Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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 Measure Information:
Title
Feasibility of study procedures measured by percentage of enrolled participants who complete the study
Time Frame
4-weeks
Title
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
Title
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
Title
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
Title
Reaction time to Urinary Stroop Task
Description
Change in reaction time to words associated with urgency
Time Frame
Baseline to 1 week
Title
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
Title
Urge Urinary Incontinence (UUI) Incidence
Description
Change in the number of UUI Incidences
Time Frame
Baseline to 1 week
Secondary Outcome Measure Information:
Title
Treatment Change
Description
Treatment change will be examined by plotting the slope and linearity of daily bladder diary and urgency survey data
Time Frame
4 weeks
Title
Individual Differences as measured by age, years of UUI and baseline measures as moderators of the efficacy of the intervention
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Conklin, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Becky Clarkson, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
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