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Mindfulness + tDCS to Reduce Urgency Incontinence in Women
NA trial testing Transcranial direct current stimulation in Urinary Incontinence, Urge in 61 participants. Completed in 10 February 2023.
| Lead sponsor | Cynthia Conklin |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 21 May 2021 |
| Primary completion | 3 February 2023 |
| Estimated completion | 10 February 2023 |
| Sites | 1 location across United States |
Cynthia Conklin
40 and older, female only, with Urinary Incontinence, Urge. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility is measured as the number of participants who completed the study divided by the total number of participants who started the intervention.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | 100 | |
| Transcranial Direct Current Stimulation (tDCS) | 90.4 | |
| Mindfulness + tDCS | 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | 85.6 | ± 9.9 |
| Transcranial Direct Current Stimulation (tDCS) | 83.4 | ± 13.6 |
| Mindfulness + tDCS | 80.4 | ± 12.8 |
Compliance with study procedures measured by 2-items with a 0-100 scale on the Post-Study Survey. A higher score indicates greater compliance.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | 88.3 | ± 12.9 |
| Transcranial Direct Current Stimulation (tDCS) | 84.1 | ± 9.4 |
| Mindfulness + tDCS | 90.5 | ± 10.0 |
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | 94.4 | ± 8.6 |
| Mindfulness + tDCS | 93.0 | ± 10.3 |
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 f
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | -25 | ± 20 |
| Transcranial Direct Current Stimulation (tDCS) | -35 | ± 13 |
| Mindfulness + tDCS | -19 | ± 18 |
Change in reaction time to words associated with urgency from baseline to post-intervention. A lower score indicates greater reduction in reaction time.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | -36.95 | ± 102.25 |
| Transcranial Direct Current Stimulation (tDCS) | -16.89 | ± 87.30 |
| Mindfulness + tDCS | -81.63 | ± 78.31 |
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 i
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | -2.65 | ± 0.79 |
| Transcranial Direct Current Stimulation (tDCS) | -2.36 | ± 0.81 |
| Mindfulness + tDCS | -2.10 | ± 0.79 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Training | -0.81 | ± 0.23 |
| Transcranial Direct Current Stimulation (tDCS) | -0.90 | ± 0.24 |
| Mindfulness + tDCS | -0.95 | ± 0.23 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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