Mindfulness + tDCS to Reduce Urgency Incontinence in Women

NCT04652869, Not applicable, Completed, Cynthia Conklin; results first posted 2024-05-31

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Mindfulness + tDCS to Reduce Urgency Incontinence in Women	ClinicalTrials.gov
NCT number	NCT04652869	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	61 participants, actual	ClinicalTrials.gov
Lead sponsor	Cynthia Conklin	ClinicalTrials.gov
Conditions	Urinary Incontinence, Urge	ClinicalTrials.gov
Interventions	Transcranial direct current stimulation, Mindfulness	ClinicalTrials.gov
First posted	2020-12-03	ClinicalTrials.gov
Last updated	2024-05-31	ClinicalTrials.gov
Results first posted	2024-05-31	ClinicalTrials.gov

Registered outcomes 7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	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.	ClinicalTrials.gov
Primary	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.	ClinicalTrials.gov
Primary	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.	ClinicalTrials.gov
Primary	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	ClinicalTrials.gov
Primary	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.	ClinicalTrials.gov
Primary	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.	ClinicalTrials.gov
Primary	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.	ClinicalTrials.gov

Outcomes 7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study	4-weeks post intervention	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	percentage of participants who completed	NUMBER	ClinicalTrials.gov
PRIMARY	Acceptability of Study Procedures	4-weeks post intervention	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.	score on a scale	MEAN	ClinicalTrials.gov
PRIMARY	Compliance With Study Procedures	4-weeks post intervention	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.	score on a scale	MEAN	ClinicalTrials.gov
PRIMARY	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	Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).	score on a scale	MEAN	ClinicalTrials.gov
PRIMARY	Reaction Time to Urinary Stroop Task	Baseline (pre-intervention) to 1 week after completion of intervention activities	Due to computer error at the time of data collection, data were not collected for three participants for this analysis (one per group).	milliseconds	MEAN	ClinicalTrials.gov
PRIMARY	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		score on a scale	MEAN	ClinicalTrials.gov
PRIMARY	Change in Number of Urge Urinary Incontinence (UUI) Episodes After Intervention	Baseline (pre-intervention) to 1 week after completion of intervention activities		Number of incontinence episodes/day	MEAN	ClinicalTrials.gov

Results by group 23

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study	Mindfulness Training		100		percentage of participants who completed	ClinicalTrials.gov
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study	Transcranial Direct Current Stimulation (tDCS)		90.4		percentage of participants who completed	ClinicalTrials.gov
Feasibility of Study Procedures Measured by Percentage of Participants Starting Intervention Who Complete the Study	Mindfulness + tDCS		100		percentage of participants who completed	ClinicalTrials.gov
Acceptability of Study Procedures	Mindfulness Training		85.6	Standard Deviation 9.9	score on a scale	ClinicalTrials.gov
Acceptability of Study Procedures	Transcranial Direct Current Stimulation (tDCS)		83.4	Standard Deviation 13.6	score on a scale	ClinicalTrials.gov
Acceptability of Study Procedures	Mindfulness + tDCS		80.4	Standard Deviation 12.8	score on a scale	ClinicalTrials.gov
Compliance With Study Procedures	Mindfulness Training	Diary Compliance	88.3	Standard Deviation 12.9	score on a scale	ClinicalTrials.gov
Compliance With Study Procedures	Transcranial Direct Current Stimulation (tDCS)	Diary Compliance	84.1	Standard Deviation 9.4	score on a scale	ClinicalTrials.gov
Compliance With Study Procedures	Mindfulness + tDCS	Diary Compliance	90.5	Standard Deviation 10.0	score on a scale	ClinicalTrials.gov
Compliance With Study Procedures	Mindfulness Training	Mindfulness Compliance	94.4	Standard Deviation 8.6	score on a scale	ClinicalTrials.gov
Compliance With Study Procedures	Mindfulness + tDCS	Mindfulness Compliance	93.0	Standard Deviation 10.3	score on a scale	ClinicalTrials.gov
Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.	Mindfulness Training		-25	Standard Error 20	score on a scale	ClinicalTrials.gov
Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.	Transcranial Direct Current Stimulation (tDCS)		-35	Standard Error 13	score on a scale	ClinicalTrials.gov
Change From Baseline to Post-intervention in Cue-induced Reactivity to Personal Photographic Urge Cues.	Mindfulness + tDCS		-19	Standard Error 18	score on a scale	ClinicalTrials.gov
Reaction Time to Urinary Stroop Task	Mindfulness Training		-36.95	Standard Deviation 102.25	milliseconds	ClinicalTrials.gov
Reaction Time to Urinary Stroop Task	Transcranial Direct Current Stimulation (tDCS)		-16.89	Standard Deviation 87.30	milliseconds	ClinicalTrials.gov
Reaction Time to Urinary Stroop Task	Mindfulness + tDCS		-81.63	Standard Deviation 78.31	milliseconds	ClinicalTrials.gov
Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)	Mindfulness Training		-2.65	Standard Error 0.79	score on a scale	ClinicalTrials.gov
Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)	Transcranial Direct Current Stimulation (tDCS)		-2.36	Standard Error 0.81	score on a scale	ClinicalTrials.gov
Change From Baseline in Severity of Bladder Problem Measured by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)	Mindfulness + tDCS		-2.10	Standard Error 0.79	score on a scale	ClinicalTrials.gov

Participant flow 9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Mindfulness Training	20	ClinicalTrials.gov
Overall Study	STARTED	Transcranial Direct Current Stimulation (tDCS)	21	ClinicalTrials.gov
Overall Study	STARTED	Mindfulness + tDCS	20	ClinicalTrials.gov
Overall Study	COMPLETED	Mindfulness Training	20	ClinicalTrials.gov
Overall Study	COMPLETED	Transcranial Direct Current Stimulation (tDCS)	19	ClinicalTrials.gov
Overall Study	COMPLETED	Mindfulness + tDCS	20	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Mindfulness Training	0	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Transcranial Direct Current Stimulation (tDCS)	2	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Mindfulness + tDCS	0	ClinicalTrials.gov

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 9

The totals the trial posted for each group.

Total	Group	At risk	Source
Total, all-cause mortality	Mindfulness Training	20	ClinicalTrials.gov
Total, all-cause mortality	Transcranial Direct Current Stimulation (tDCS)	21	ClinicalTrials.gov
Total, all-cause mortality	Mindfulness + tDCS	20	ClinicalTrials.gov
Total, other adverse events	Mindfulness Training	20	ClinicalTrials.gov
Total, other adverse events	Transcranial Direct Current Stimulation (tDCS)	21	ClinicalTrials.gov
Total, other adverse events	Mindfulness + tDCS	20	ClinicalTrials.gov
Total, serious adverse events	Mindfulness Training	20	ClinicalTrials.gov
Total, serious adverse events	Transcranial Direct Current Stimulation (tDCS)	21	ClinicalTrials.gov
Total, serious adverse events	Mindfulness + tDCS	20	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R21AG064361	Mindfulness + tDCS to Reduce Situational Urgency Incontinence in Women	CONKLIN, CYNTHIA A.; CLARKSON, BECKY D	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL INSTITUTE ON AGING	2020 to 2021	NIH RePORTER

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Food Cue Reactivity Task	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)