Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence

(SLAB Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Shachi Tyagi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Shachi Tyagi

Must not be taking: Anticholinergics, Antibiotics

Disqualifiers: Cognitive impairment, Spinal injury, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among older adults, and the brain mechanisms involved in continence by evaluating brain changes. This will expand the current knowledge of how the sleep affects bladder control, and better characterize the brain mechanisms in maintaining continence.

Do I have to stop taking my current medications for the trial?

If you are currently using anticholinergic medications, you must go through a washout period of at least 4 weeks. The protocol does not specify other medication restrictions, but you should discuss your current medications with the trial team.

What data supports the idea that Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence is an effective treatment?

The available research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for improving sleep-related issues, such as reducing the time it takes to fall asleep and decreasing awakenings during the night. Studies have shown that CBT-I is feasible, acceptable, and effective, with improvements maintained over time. However, the research provided does not specifically address the combination of Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence, nor does it compare this combination to other treatments for urinary incontinence. ^{1 2 3 4 5}

What safety data exists for Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence?

The provided research primarily discusses the efficacy and acceptability of Cognitive Behavioral Therapy for Insomnia (CBT-I) and its variants, such as Brief Behavioral Treatment for Insomnia (BBTI), in various populations, including military personnel and veterans. While these studies highlight the effectiveness and patient preferences for CBT-I, they do not specifically address the safety data for the combination of Behavioral Sleep Treatment and Mirabegron for Urinary Incontinence. Therefore, the safety data for this specific combination treatment is not covered in the provided research. ^{1 6 7 8 9}

Is the treatment Brief Behavioral Treatment for Insomnia a promising treatment for urinary incontinence?

Yes, Brief Behavioral Treatment for Insomnia, also known as Cognitive Behavioral Therapy for Insomnia (CBT-I), is a promising treatment. It has been shown to be effective in improving sleep in various groups, including those with traumatic brain injuries, asthma, and veterans with sleep difficulties. This suggests it could be beneficial for urinary incontinence as well, as better sleep can improve overall health and well-being. ^{1 2 3 8 10}

Research Team

Shachi Tyagi, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for ambulatory women aged 60 and older who experience frequent urgency urinary incontinence or urge-predominant mixed incontinence, despite treatment. Participants should have nocturia (waking up to urinate) at least twice each night and be willing to stop any anticholinergic medications for four weeks before the study.

Inclusion Criteria

I get up to urinate 2 or more times each night.

I am willing to stop taking my anticholinergic medications for at least 4 weeks.

I have had frequent urgent or mixed incontinence for over 3 months despite treatment.

Exclusion Criteria

You have trouble thinking clearly or remembering things (MOCA score less than 24 or difficulty completing certain tasks).

I do not have specific conditions like spinal injury, severe bladder issues, MS, or uncontrolled high blood pressure.

I am allergic or cannot take certain medications like mirabegron.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mirabegron for 8 weeks, with or without a 4-week behavioral sleep intervention

8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, assessing durability of combination therapy

6 months

Treatment Details

Interventions

• Brief Behavioral Treatment for Insomnia (Behavioral Intervention)

Trial Overview The study tests whether adding a behavioral sleep intervention improves bladder control in older women with urinary issues when combined with standard drug therapy using Mirabegron. It also examines brain changes related to continence through fMRI scans.

Participant Groups

Group I: Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI) Experimental Treatment 2 Interventions

Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia

Group II: Mirabegron Experimental Treatment 1 Intervention

Mirabegron for 8 weeks

Who Is Running the Clinical Trial?

Shachi Tyagi

Lead Sponsor

Trials

1

Recruited

120+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

Cognitive Behavioral Therapy (CBT) for insomnia significantly improved sleep quality in a man with a traumatic brain injury, reducing sleep onset time from 47 to 18 minutes and nocturnal awakenings from 85 to 28 minutes after eight weekly sessions.

Polysomnography confirmed these improvements, showing a decrease in total awake time and number of awakenings, with benefits maintained at 1- and 3-month follow-ups, indicating that CBT could be an effective non-drug treatment for insomnia following TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. Ouellet, MC., Morin, CM.[2018]

Group-based cognitive behavioral therapy for insomnia (CBT-I) is a feasible and acceptable treatment for veterans with insomnia, showing medium to large effect sizes in improving various sleep measures.

The treatment demonstrated initial effectiveness in reducing insomnia symptoms, with improvements maintained for at least one month after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. Koffel, E., Farrell-Carnahan, L.[2018]

Cognitive-behavioral therapy (CBT) for insomnia was effective in reducing total wake time and improving sleep efficiency in 73% of participants with traumatic brain injury (TBI), with an average 53.9% reduction in wake time after 8 weeks of treatment.

Participants showed significant improvements in sleep efficiency from 77.2% before treatment to 87.9% after treatment, and these benefits were maintained at 3-month follow-up, indicating that CBT can be a promising intervention for insomnia in TBI survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Ouellet, MC., Morin, CM.[2015]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep parameters in 51 patients with chronic insomnia, including reductions in sleep latency, number of awakenings, and overall sleep quality, with effects lasting for at least 3 months after treatment.

Post-treatment, patients with insomnia showed no significant differences in sleep quality and mental health symptoms compared to healthy controls, indicating that CBT-I can effectively restore normal sleep patterns and improve overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. Fornal-Pawłowska, M., Szelenberger, W.[2018]

A survey of 154 military sleep health care providers revealed that while 68% reported availability of cognitive-behavioral treatment for insomnia (CBTI/BBTI), less than 50% of patients diagnosed with insomnia actually receive these treatments, indicating a significant gap in care.

Key barriers to implementing CBTI/BBTI include under-resourced clinics and scheduling limitations, while facilitators include having trained providers and leadership support, suggesting that improving resources and workflows could enhance insomnia treatment for service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. Germain, A., Wolfson, M., Klenczar, B., et al.[2023]

Cognitive-behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms among 98 active duty military personnel, with 20% achieving clinically meaningful improvement after treatment.

Significant improvements in sleep quality were observed in patients who completed 4 or more sessions of CBT-I, while those who had fewer than 4 sessions did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia among active duty military personnel. Lee, MRG., Breitstein, J., Hoyt, T., et al.[2021]

Cognitive-behavioral treatment for insomnia (CBT-I) may need to be modified for OIF/OEF Veterans due to their unique experiences with trauma and brain injuries, as traditional methods require high motivation and adherence.

Veterans preferred relaxation treatments and pharmacotherapy for insomnia, with a strong inclination towards individual and electronic delivery methods, indicating a need for tailored interventions that align with their preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia treatment acceptability and preferences of male Iraq and Afghanistan combat veterans and their healthcare providers. Epstein, DR., Babcock-Parziale, JL., Haynes, PL., et al.[2019]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

A study involving 210 adults with chronic insomnia and poorly controlled asthma will assess the effectiveness of a 9-week Internet-based cognitive-behavioral treatment for insomnia (CBT-I) on improving both sleep and asthma control.

The research aims to explore whether improvements in sleep quality can lead to better asthma management by examining biological markers like airway inflammation, potentially providing a new approach to asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. Shi, X., Buysse, DJ., Ritterband, LM., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. [2019]

5. Poland pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia among active duty military personnel. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Insomnia treatment acceptability and preferences of male Iraq and Afghanistan combat veterans and their healthcare providers. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. [2023]