Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04652869 |
Other study ID # |
STUDY19110132 |
Secondary ID |
1R21AG064361 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 21, 2021 |
Est. completion date |
February 10, 2023 |
Study information
Verified date |
February 2023 |
Source |
University of Pittsburgh |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.