Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence
(SLAB Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Brief Behavioral Treatment for Insomnia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shachi Tyagi
Lead Sponsor
National Institute on Aging (NIA)
Collaborator