Trial Outcomes & Findings for Mindfulness + tDCS to Reduce Urgency Incontinence in Women (NCT NCT04652869)

Last Updated: 2024-05-31

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

4-weeks post intervention

Results posted on

2024-05-31

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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	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.
Overall Study STARTED	20	21	20
Overall Study COMPLETED	20	19	20
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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	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.
Overall Study Withdrawal by Subject	0	2	0

Baseline Characteristics

Mindfulness + tDCS to Reduce Urgency Incontinence in Women

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Mindfulness Training n=20 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=21 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study	100 percentage of participants who completed	90.4 percentage of participants who completed	100 percentage of participants who completed

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mindfulness Training n=18 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=17 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.
Acceptability of Study Procedures	85.6 score on a scale Standard Deviation 9.9	83.4 score on a scale Standard Deviation 13.6	80.4 score on a scale Standard Deviation 12.8

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Mindfulness Training n=18 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=17 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.
Compliance With Study Procedures Diary Compliance	88.3 score on a scale Standard Deviation 12.9	84.1 score on a scale Standard Deviation 9.4	90.5 score on a scale Standard Deviation 10.0
Compliance With Study Procedures Mindfulness Compliance	94.4 score on a scale Standard Deviation 8.6	—	93.0 score on a scale Standard Deviation 10.3

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Mindfulness Training n=19 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=18 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=19 Participants 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.
Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.	-25 score on a scale Standard Error 20	-35 score on a scale Standard Error 13	-19 score on a scale Standard Error 18

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Mindfulness Training n=19 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=18 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=19 Participants 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.
Reaction Time to Urinary Stroop Task	-36.95 milliseconds Standard Deviation 102.25	-16.89 milliseconds Standard Deviation 87.30	-81.63 milliseconds Standard Deviation 78.31

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness Training n=20 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=19 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.
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	-2.36 score on a scale Standard Error 0.81	-2.10 score on a scale Standard Error 0.79

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness Training n=20 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=19 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.
Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention	-0.81 Number of incontinence episodes/day Standard Error 0.23	-0.90 Number of incontinence episodes/day Standard Error 0.24	-0.95 Number of incontinence episodes/day Standard Error 0.23

Adverse Events

Mindfulness Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transcranial Direct Current Stimulation (tDCS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mindfulness + tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cynthia Conklin

University of Pittsburgh

Phone: 4125869840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mindfulness Training n=20 Participants 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.	Transcranial Direct Current Stimulation (tDCS) n=21 Participants Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex Transcranial direct current stimulation: Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex	Mindfulness + tDCS n=20 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	21 Participants n=4 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 9.8 • n=5 Participants	58.0 years STANDARD_DEVIATION 8.9 • n=7 Participants	64.8 years STANDARD_DEVIATION 12.8 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants