Urinary Incontinence, Urge
Conditions
Keywords
Transcranial Direct Current Stimulation (tDCS), Mindfulness, Situational Urge Urinary Incontinence
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.
Interventions
DEVICETranscranial direct current stimulation
Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
BEHAVIORALMindfulness
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.
Sponsors
National Institute on Aging (NIA)
Cynthia Conklin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study | 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. |
| Acceptability of Study Procedures | 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. |
| Compliance With Study Procedures | 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. |
| Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues. | 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 |
| Reaction Time to Urinary Stroop Task | 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. |
| Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | 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. |
| Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred by telephone screening respondents to research registries (Pitt+Me and the Pepper Research Registry of Older Adults), online advertising, other advertisements (flyers in senior centers and public places i.e. libraries, coffee shops, senior centers, hospital noticeboards), and referrals from the Benedum Geriatric center, local urogynecologists and urologists, faculty geriatricians, and local women's health and continence centers.
Pre-assignment details
Participant exclusion prior to randomization occurred if the participant did not have enough urgency places, failed a urine screen, did not react to urgency cues at pre-test cue-reactivity, or chose not to continue participation after session 1.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Training Mindfulness training
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. | 20 |
| Transcranial Direct Current Stimulation (tDCS) Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex | 21 |
| Mindfulness + tDCS Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
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. | 20 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Mindfulness Training | Transcranial Direct Current Stimulation (tDCS) | Mindfulness + tDCS |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 6 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 14 Participants | 17 Participants | 9 Participants |
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.8 | 59.3 years STANDARD_DEVIATION 9.8 | 58.0 years STANDARD_DEVIATION 8.9 | 64.8 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 19 Participants | 20 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 3 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 14 Participants | 15 Participants | 16 Participants |
| Sex: Female, Male Female | 61 Participants | 20 Participants | 21 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 20 |
Outcome results
Primary
Acceptability of Study Procedures
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.
Time frame: 4-weeks post intervention
Population: Analysis is based on number of mail-in acceptability questionnaires returned. Questionnaires were not returned for 2 participants in the transcranial direct current stimulation(tDCS) group and 2 participants in the Mindfulness group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Training | Acceptability of Study Procedures | 85.6 score on a scale | Standard Deviation 9.9 |
| Transcranial Direct Current Stimulation (tDCS) | Acceptability of Study Procedures | 83.4 score on a scale | Standard Deviation 13.6 |
| Mindfulness + tDCS | Acceptability of Study Procedures | 80.4 score on a scale | Standard Deviation 12.8 |
Primary
Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
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.
Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Training | Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | -2.65 score on a scale | Standard Error 0.79 |
| Transcranial Direct Current Stimulation (tDCS) | Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | -2.36 score on a scale | Standard Error 0.81 |
| Mindfulness + tDCS | Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) | -2.10 score on a scale | Standard Error 0.79 |
Primary
Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.
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
Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities
Population: Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Training | Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues. | -25 score on a scale | Standard Error 20 |
| Transcranial Direct Current Stimulation (tDCS) | Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues. | -35 score on a scale | Standard Error 13 |
| Mindfulness + tDCS | Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues. | -19 score on a scale | Standard Error 18 |
Primary
Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention
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.
Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Training | Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention | -0.81 Number of incontinence episodes/day | Standard Error 0.23 |
| Transcranial Direct Current Stimulation (tDCS) | Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention | -0.90 Number of incontinence episodes/day | Standard Error 0.24 |
| Mindfulness + tDCS | Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention | -0.95 Number of incontinence episodes/day | Standard Error 0.23 |
Primary
Compliance With Study Procedures
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 post intervention
Population: Transcranial Direct Current Stimulation group did not answer mindfulness compliance question. Analysis is based on number of mail-in acceptability questionnaires returned. Questionnaires were not returned for 2 participants in the transcranial direct current stimulation(tDCS) group and 2 participants in the Mindfulness group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training | Compliance With Study Procedures | Diary Compliance | 88.3 score on a scale | Standard Deviation 12.9 |
| Mindfulness Training | Compliance With Study Procedures | Mindfulness Compliance | 94.4 score on a scale | Standard Deviation 8.6 |
| Transcranial Direct Current Stimulation (tDCS) | Compliance With Study Procedures | Diary Compliance | 84.1 score on a scale | Standard Deviation 9.4 |
| Mindfulness + tDCS | Compliance With Study Procedures | Diary Compliance | 90.5 score on a scale | Standard Deviation 10 |
| Mindfulness + tDCS | Compliance With Study Procedures | Mindfulness Compliance | 93.0 score on a scale | Standard Deviation 10.3 |
Primary
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study
Feasibility is measured as the number of participants who completed the study divided by the total number of participants who started the intervention.
Time frame: 4-weeks post intervention
Population: Number of participants that started the intervention (i.e. attended the first intervention visit) was 61. Thus, 61 participants started the intervention, and 59 participant completed all visits and intervention procedures
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Training | Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study | 100 percentage of participants who completed |
| Transcranial Direct Current Stimulation (tDCS) | Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study | 90.4 percentage of participants who completed |
| Mindfulness + tDCS | Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study | 100 percentage of participants who completed |
Primary
Reaction Time to Urinary Stroop Task
Change in reaction time to words associated with urgency from baseline to post-intervention. A lower score indicates greater reduction in reaction time.
Time frame: Baseline (pre-intervention) to 1 week after completion of intervention activities
Population: Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Training | Reaction Time to Urinary Stroop Task | -36.95 milliseconds | Standard Deviation 102.25 |
| Transcranial Direct Current Stimulation (tDCS) | Reaction Time to Urinary Stroop Task | -16.89 milliseconds | Standard Deviation 87.3 |
| Mindfulness + tDCS | Reaction Time to Urinary Stroop Task | -81.63 milliseconds | Standard Deviation 78.31 |