Skip to main content
OpenTrials
Completed

NCT Number: NCT04652869

Mindfulness + tDCS to Reduce Urgency Incontinence in Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence, Urge Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Other names: tDCS

Mindfulness

Behavioral

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 outcomes

  1. Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study

    Time frame: 4-weeks post intervention

    Feasibility is measured as the number of participants who completed the study divided by the total number of participants who started the intervention.

  2. Acceptability of Study Procedures

    Time frame: 4-weeks post intervention

    Acceptability of study procedures was measured by 8-items assessing burden, difficulty, likeability of the study procedures on a 0-100 scale on the Post-Study Survey. A higher score indicates greater acceptability.

  3. Compliance With Study Procedures

    Time frame: 4-weeks post intervention

    Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance.

  4. Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.

    Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities

    Urinary urgency in response to personal photographic cues was self-reported by participants on 4 post-picture trial questions. Ratings were done using a 0-100 scale. The 4 items were averaged to calculate an urgency cue rating and safe cue rating for each picture trial. An overall Cue reactivity urgency rating was calculated for each participant by averaging their total urgency cue trial ratings. The same was done for safe cues.

    Cue reactivity was calculated as the difference between the overall rating averages for urgency cues and safe cues.

    Cue reactivity post-intervention was subtracted from that calculated for baseline. A lower score indicates greater reduction in cue-reactivity

  5. Reaction Time to Urinary Stroop Task

    Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities

    Change in reaction time to words associated with urgency from baseline to post-intervention. A lower score indicates greater reduction in reaction time.

  6. Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

    Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities

    Change from baseline in severity of bladder problem measured by the ICIQ-FLUTS (International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms) a 12-item questionnaire (each item rated 0-4) evaluating urinary tract symptoms and impact on quality of life. A higher total score indicates greater symptoms and greater impact on quality of life. Score range (0-48) ICIQ-FLUTS was completed at baseline (pre-intervention) and one week after completion of all intervention activities. Pre-intervention score was subtracted from post-intervention score. A more negative score indicates greater symptom reduction.

  7. Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention

    Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities

    Change in the number of Urge Urinary Incontinence (UUI) episodes was calculated from the mean number of incontinence episodes per day reported on a 3-day bladder diary pre-treatment and mean the number of UUI episodes per day on a 7-day bladder diary measured the week immediately after intervention concluded (post treatment). Post-intervention mean was subtracted from baseline mean. A more negative score indicates greater reduction in UUI episodes.

Sponsors and collaborators

Lead sponsor

Cynthia Conklin

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.