Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence

(SLAB Trial)

Overseen By Shachi Tyagi, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Shachi Tyagi

Must not be taking: Anticholinergics, Antibiotics

Disqualifiers: Cognitive impairment, Spinal injury, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage urgency urinary incontinence (UUI) in older women. It will test whether adding a sleep treatment to the usual medication improves bladder control and overall quality of life. The trial will also examine the brain's role in continence. Women aged 60 and over who experience sudden, strong urges to urinate at least five times a week for three months may qualify for this study. Participants will receive either the usual medication, mirabegron, or the medication combined with a sleep intervention (Brief Behavioral Treatment for Insomnia). As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for these treatments?

Previous studies have shown that mirabegron is safe for treating overactive bladder (OAB). Research has examined its safety in adults through several trials, including one lasting a year. About 6.3% of patients experienced side effects, mostly in the first month, indicating the treatment is generally well-tolerated over time.

There is less direct data on using mirabegron with Brief Behavioral Treatment for Insomnia (BBTI). However, since mirabegron is already approved for OAB, it suggests safety. Adding BBTI, a non-drug method, likely doesn't increase risk. Overall, these findings suggest that the treatments in this study are generally safe for people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for urinary incontinence, which often include anticholinergics or surgical options, Mirabegron works by relaxing the bladder muscle to increase storage capacity, addressing the overactive bladder symptom. Researchers are excited about combining Mirabegron with Brief Behavioral Treatment for Insomnia (BBTI) because it targets both urinary and sleep issues simultaneously, which could improve overall patient quality of life. This dual approach not only aims to alleviate urinary symptoms but also addresses insomnia, a common problem among those with incontinence, potentially offering a more comprehensive treatment solution.

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

Studies have shown that mirabegron helps reduce episodes of urinary incontinence. For example, it decreased the average number of daily incontinence episodes in people over 65 and outperformed placebo treatments. In this trial, some participants will receive mirabegron alone, while others will receive a combination of mirabegron with a sleep-focused behavioral treatment. This combination might further improve bladder control and help with sleep and urinary issues, especially in older adults. ^{6 7 8 9 10}

Who Is on the Research Team?

Shachi Tyagi, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Treatment for Insomnia

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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-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 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 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 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]

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]

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]

A clinical study involving 123 insomnia patients followed for an average of 7.8 years showed that cognitive-behavioral therapy for insomnia (CBT-I) significantly improved insomnia severity and maintained its effects for up to 10 years after treatment.

Patients who relied solely on CBT-I techniques for managing relapses had better long-term outcomes compared to those who resorted to medication, highlighting the effectiveness of CBT-I as a first-choice treatment for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. Castronovo, V., Galbiati, A., Sforza, M., et al.[2019]

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