Mindfulness + tDCS for Urge Incontinence

Overseen By Cynthia Conklin, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cynthia Conklin

Disqualifiers: Cognitive impairment, Urinary retention, Interstitial cystitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help women with urge urinary incontinence (UUI), characterized by a sudden need to urinate and occasional leakage. Researchers are testing whether mindfulness techniques and a gentle brain stimulation method called transcranial direct current stimulation (tDCS) can reduce these symptoms by decreasing reactions to triggers. Women suitable for this trial typically experience frequent urgency in at least four common situations and have two or more leaks per week. The goal is to find effective, non-drug treatments to improve the daily lives of those with UUI. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new, non-drug solutions for UUI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments, so it's best to ask the trial organizers for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness is generally safe and well-tolerated, helping with stress, anxiety, and pain without causing many harmful effects. Few reports exist of significant side effects from practicing mindfulness.

Studies indicate that transcranial direct current stimulation (tDCS) is safe and non-invasive. tDCS applies a gentle electric current to the scalp. Most people do not experience serious side effects, though some might feel a slight tingling or mild headache, which are not severe.

When combined, mindfulness and tDCS show promise in reducing symptoms of urinary incontinence. Studies suggest they work well together, with no major safety concerns reported. They offer a potential new way to ease these symptoms without using drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of mindfulness and transcranial direct current stimulation (tDCS) for treating urgency incontinence in women because these approaches offer novel, non-invasive methods compared to traditional treatments like pelvic floor exercises or medications. Mindfulness training encourages mental focus and stress reduction, which can help manage symptoms by improving awareness and control over bodily functions. tDCS, on the other hand, involves gentle electrical stimulation targeting the dorsolateral prefrontal cortex, potentially enhancing brain activity related to bladder control. Combining mindfulness with tDCS could provide a powerful, drug-free alternative that reduces symptoms more effectively by addressing both the psychological and neurological aspects of incontinence.

What evidence suggests that this trial's treatments could be effective for urge urinary incontinence?

Research has shown that mindfulness, one of the treatments in this trial, can improve emotional and mental well-being. It effectively manages symptoms of depression and anxiety and enhances focus and emotional control. Transcranial direct current stimulation (tDCS), another treatment option in this trial, has shown promise in reducing depression symptoms and boosting brain function. The trial will also explore combining mindfulness with tDCS, which studies suggest might further enhance thinking skills and reduce anxiety. This combination has proven effective in various groups, such as stroke survivors and individuals with substance use issues. While specific data for urinary incontinence is limited, the positive results in related areas are encouraging. ^{2 6 7 8 9}

Who Is on the Research Team?

Cynthia Conklin, PhD

Principal Investigator

University of Pittsburgh

Becky Clarkson, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

Female; 40+ years old

Self-report situational urgency in at least 4 of 15 common scenarios

At least 2 leaks/week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 7 sessions of mindfulness training, transcranial direct current stimulation (tDCS), or a combination of both, with 4 urgency-cue exposure training sessions.

7 weeks

7 sessions (in-person)

Follow-up

Participants are monitored for changes in urgency and compliance with study procedures, including a mail-in follow-up 1 week post-training.

4 weeks

Mail-in follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness
• Transcranial direct current stimulation

How Is the Trial Designed?

Group I: Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Group II: Mindfulness Training Experimental Treatment 1 Intervention

Mindfulness training

Group III: Mindfulness + tDCS Experimental Treatment 2 Interventions

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

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Cynthia Conklin

Lead Sponsor

Trials

2

Recruited

100+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a pilot study involving 30 female patients with chronic migraine, combining mindfulness sessions with anodal transcranial direct-current stimulation (tDCS) over the left dorsolateral prefrontal cortex significantly improved migraine-related outcomes compared to a sham treatment.

The active treatment group showed better results in all evaluated measures, particularly in the Headache Impact Test (HIT-6), indicating that this combined approach may enhance attention and provide analgesic benefits for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Synergism of Mindfulness Practice Associated With Transcranial Direct-Current Stimulation in Chronic Migraine: Pilot, Randomized, Controlled, Double-Blind Clinical Trial. Pimenta, LDS., de Araújo, ELM., Silva, JPDS., et al.[2021]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

The review analyzed 10 randomized clinical trials involving 461 participants that combined mind-body therapies (like meditation and mindfulness) with transcranial direct current stimulation (tDCS), a technique that enhances brain activity and neuroplasticity.

The combination of MBTs and tDCS shows promise for improving treatment outcomes, but the studies varied widely in design and population, indicating a need for more standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. Rebello-Sanchez, I., Vasquez-Avila, K., Parente, J., et al.[2023]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

Over the past two decades, there has been a significant increase in randomized controlled trials (RCTs) on mindfulness, with 1389 publications showing a near-exponential growth, particularly in the United States, United Kingdom, and Netherlands.

The most common mindfulness modalities studied include acceptance-based therapy and mindfulness-based stress reduction, with a notable rise in remote delivery methods, indicating a shift towards more accessible mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trials of Mindfulness and Acceptance-Based Interventions Over the Past Two Decades: A Bibliometric Analysis. Ma, Y., Kraemer, KM., Lyu, J., et al.[2022]

Citations

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Mindfulness-based interventions: an overall review - PMC A systematic review and meta-analysis found that MBIs led to a statistically significant reduction in cancer-related fatigue (CRF) score among ...

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Effectiveness of Mindfulness-Based Cognitive Therapy for ... Results: The results showed that cognitive aspect of subjective well-being and mindfulness skills were significantly improved at 8 weeks, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666915325000599

The efficacy of mindfulness-based cognitive therapy in ... The results support that MBCT effectively manages the symptoms of depressive disorders and regulates cognition and emotions. Conclusion. MBCT, when implemented ...

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Effect of Mindfulness-Based Stress Reduction vs Cognitive ... Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.

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Home practice in Mindfulness-Based Cognitive Therapy ... Effectiveness of mindfulness-based stress reduction in mood, breast- and endocrine-related quality of life, and well-being in stage 0 to III breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5679245/

Mindfulness-Based Interventions for Anxiety and Depression This article reviews the ways in which cognitive and behavioral treatments for depression and anxiety have been advanced by the application of mindfulness ...

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Systematic review and individual participant data meta- ... Mindfulness-based programs (MBPs) are widely used to prevent mental ill health. Evidence suggests beneficial average effects but wide variability.

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Doing no harm in mindfulness-based programs Potential harmful outcomes of mindfulness-based programs are under-researched. Harm occurs in psychotherapy, pharmacotherapy, physical exercise, and meditation.

9. mdpi.com mdpi.com/2077-0383/14/5/1703

Mindfulness-Based Cognitive Therapy in Clinical Practice MBCT is a clinical intervention that integrates cognitive therapy with mindfulness practices to prevent depression relapses and improve mental health.