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Behavioral Sleep Treatment + Mirabegron for Urinary Incontinence (SLAB Trial)
Phase 4
Recruiting
Led By Shachi Tyagi, MD
Research Sponsored by Shachi Tyagi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nocturia ≥2 each night
Diagnosis of urgency incontinence or urge-predominant mixed incontinence occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights
SLAB Trial Summary
This trial will study how sleep can help treat urgency urinary incontinence in older adults, and how it affects brain changes related to continence.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions to Mirabegron such as increased blood pressure, headache, dry mouth, constipation, and potential insomnia-related impacts from the behavioral intervention.
SLAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I get up to urinate 2 or more times each night.
Select...
I have had frequent urgent or mixed incontinence for over 3 months despite treatment.
Select...
I am a woman over 60 years old and can walk.
SLAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incontinence episodes
Secondary outcome measures
Functional brain changes
Nocturia
Structural brain changes
SLAB Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron 50 MG
2022
Completed Phase 4
~100
Brief Behavioral Treatment for Insomnia
2016
N/A
~660
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,543 Total Patients Enrolled
2 Trials studying Nocturia
86 Patients Enrolled for Nocturia
Shachi TyagiLead Sponsor
Shachi Tyagi, MDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I get up to urinate 2 or more times each night.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.I have had Botox injections or nerve stimulation therapy for bladder control.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.I am a woman over 60 years old and can walk.
Research Study Groups:
This trial has the following groups:- Group 1: Mirabegron
- Group 2: Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join this research trial?
"Clinicaltrials.gov lists this trial as no longer actively recruiting, with the first posting on November 1st 2022 and a last update 8 days later. However, there are 191 other studies that currently require volunteers to join them in their research endeavours."
Answered by AI
How does Mirabegron impact the safety of users?
"The safety of Mirabegron has been thoroughly evaluated, which is why it earned a score of 3 from our team at Power. This drug is already approved for use due to the completion of Phase 4 testing."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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