Clinical trial NCT04652869: Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Official title: Mindfulness + tDCS to Reduce Urgency Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Urge
Keywords: Transcranial Direct Current Stimulation (tDCS)
Mindfulness
Situational Urge Urinary Incontinence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-03
Enrollment: 61
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prefrontal cortex (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.

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 Montreal Cognitive Assessment (MoCA) score \< 26
* Urinary retention (PVR\>200ml)
* Interstitial cystitis
* Spinal cord injury
* Pelvic irradiation or other cause of pelvic nerve damage
* Active urinary tract infection (UTI)

Primary outcomes:
measure: Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study
timeFrame: 4-weeks post intervention
measure: Acceptability of Study Procedures
timeFrame: 4-weeks post intervention
measure: Compliance With Study Procedures
timeFrame: 4-weeks post intervention
measure: Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.
timeFrame: Baseline (pre-intervention) to 1 week after completion of intervention activities
measure: Reaction Time to Urinary Stroop Task
timeFrame: Baseline (pre-intervention) to 1 week after completion of intervention activities
measure: Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: Baseline (pre-intervention) to 1 week after completion of intervention activities
measure: Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention
timeFrame: Baseline (pre-intervention) to 1 week after completion of intervention activities
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Cynthia Conklin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Becky Clarkson, PhD
role: PRINCIPAL_INVESTIGATOR
References: