Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence
(SLAB Trial)
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
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mirabegron for 8 weeks, with or without a 4-week behavioral sleep intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment, assessing durability of combination therapy
Treatment Details
Interventions
- Brief Behavioral Treatment for Insomnia (Behavioral Intervention)
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Who Is Running the Clinical Trial?
Shachi Tyagi
Lead Sponsor
National Institute on Aging (NIA)
Collaborator