Mindfulness + tDCS to Reduce Urgency Incontinence in Women

NCT04652869 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY191101321R21AG064361
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Urge

Keywords

Transcranial Direct Current Stimulation (tDCS); Mindfulness; Situational Urge Urinary Incontinence

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

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

Study Arms (3)

Mindfulness Training

EXPERIMENTAL

Mindfulness training

Behavioral: Mindfulness

Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation

Mindfulness + tDCS

EXPERIMENTAL

Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation; Behavioral: Mindfulness

Interventions

Transcranial direct current stimulation DEVICE

Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Also known as: tDCS

Mindfulness + tDCS; Transcranial Direct Current Stimulation (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.

Mindfulness + tDCS; Mindfulness Training

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cynthia Conklin: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Transcranial Direct Current Stimulation; Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy

Results Point of Contact

• Title: Dr. Cynthia Conklin
• Organization: University of Pittsburgh

conkca@upmc.edu

4125869840

Study Officials

• Cynthia Conklin, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Becky Clarkson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: May 21, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 10, 2023
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following publication, no end date
• Access Criteria: Any purpose

Locations

US (1)