~41 spots leftby May 2026

Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence

(SLAB Trial)

Recruiting in Palo Alto (17 mi)
Dr. Shachi Tyagi, MD, MS - Pittsburgh ...
Overseen byShachi 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.12345

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.16789

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.123810

Research Team

Dr. Shachi Tyagi, MD, MS - Pittsburgh ...

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.
See 1 more

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.
See 1 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)Experimental Treatment2 Interventions
Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia
Group II: MirabegronExperimental Treatment1 Intervention
Mirabegron for 8 weeks

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?

Shachi Tyagi

Lead Sponsor

Trials
1
Patients Recruited
120+

National Institute on Aging (NIA)

Collaborator

Trials
1841
Patients Recruited
28,150,000+

Findings from Research

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.
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.
Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design.Ouellet, MC., Morin, CM.[2015]
Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study.Castronovo, V., Galbiati, A., Sforza, M., et al.[2019]
[Cognitive behavioral therapy for chronic insomnia].Fornal-Pawłowska, M., Szelenberger, W.[2018]
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.
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.
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.
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders.Smith, MT., Huang, MI., Manber, R.[2022]
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

Cognitive behavioral therapy for insomnia associated with traumatic brain injury: a single-case study. [2018]
Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. [2018]
Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. [2015]
Long-term clinical effect of group cognitive behavioral therapy for insomnia: a case series study. [2019]
[Cognitive behavioral therapy for chronic insomnia]. [2018]
Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]
Cognitive behavioral therapy for insomnia among active duty military personnel. [2021]
Insomnia treatment acceptability and preferences of male Iraq and Afghanistan combat veterans and their healthcare providers. [2019]
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. [2023]