Urinary Incontinence, UrgeNCT04652869
Mindfulness + tDCS to Reduce Urgency Incontinence in Women
A study testing Transcranial direct current stimulation and Mindfulness in people with Urinary Incontinence, Urge, run by Cynthia Conklin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- Transcranial direct current stimulation and Mindfulness
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- Transcranial direct current stimulation, Mindfulness
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Mindfulness, Situational Urge Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS
Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Experimental | Mindfulness training Receives: Behavioral: Mindfulness |
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation |
| Mindfulness + tDCS | Experimental | Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation; Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-weeks post intervention
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.
Measured: 4-weeks post intervention
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.
Measured: 4-weeks post intervention
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
Measured: Baseline (pre-intervention) to 1 week after completion of intervention activities
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.
Measured: Baseline (pre-intervention) to 1 week after completion of intervention activities
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.
Measured: Baseline (pre-intervention) to 1 week after completion of intervention activities
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.
Measured: Baseline (pre-intervention) to 1 week after completion of intervention activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start21 May 2021
- Primary completion3 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Incontinence, UrgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Conklin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Cynthia Conklin, University of Pittsburgh
- Investigators
- Cynthia Conklin, PhD, Principal investigator, University of PittsburghBecky Clarkson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652869
- Sponsor's protocol ID
- STUDY19110132
- Other IDs
- 1R21AG064361
- Status last verified
- May 2024
- First submitted
- 25 Nov 2020
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness + tDCS to Reduce Urgency Incontinence in Women
- ClinicalTrials.gov ID
- NCT04652869
- Acronym / sponsor ID
- STUDY19110132
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Transcranial Direct Current Stimulation (tDCS), Mindfulness, Situational Urge Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cynthia ConklinUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: MindfulnessMindfulness training |
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: Transcranial direct current stimulationTranscranial direct current stimulation targeting the dorsolateral prefrontal cortex |
| Mindfulness + tDCS | Experimental | Device: Transcranial direct current stimulation, Behavioral: MindfulnessMindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCSTranscranial direct current stimulation targeting the dorsolateral prefrontal cortex | Device | Mindfulness + tDCS, Transcranial Direct Current Stimulation (tDCS) |
| MindfulnessMindfulness 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. | Behavioural | Mindfulness + tDCS, Mindfulness Training |
Primary outcome
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.
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.
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.
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
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification may be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Conklin, PhD principal investigator
University of Pittsburgh
Becky Clarkson, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation and Mindfulness in people with Urinary Incontinence, Urge, run by Cynthia Conklin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study (time frame: 4-weeks post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.