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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
Must not have
Specific medical conditions including spinal cord injury, history of pelvic irradiation, advanced uterine or bladder cancer, multiple sclerosis, urethral obstruction, urinary retention, interstitial cystitis, artificial sphincter implant, medical instability, conditions precluding fMRI testing, requirement for intravenous antibiotics, chronic or recurrent bowel issues, known allergy to study medication or interaction with current medications, severe uncontrolled hypertension
Contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I get up to urinate 2 or more times each night.
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I have had frequent urgent or mixed incontinence for over 3 months despite treatment.
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I am a woman over 60 years old and can walk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have specific conditions like spinal injury, severe bladder issues, MS, or uncontrolled high blood pressure.
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I am allergic or cannot take certain medications like mirabegron.
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I have had Botox injections or nerve stimulation therapy for bladder control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incontinence episodes
Secondary study objectives
Functional brain changes
Nocturia
Structural brain changes

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~670

Find a Location

Who is running the clinical trial?

Shachi TyagiLead Sponsor
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,616 Total Patients Enrolled
2 Trials studying Nocturia
86 Patients Enrolled for Nocturia
Shachi Tyagi, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Brief Behavioral Treatment for Insomnia Clinical Trial Eligibility Overview. Trial Name: NCT05604222 — Phase 4
Nocturia Research Study Groups: Mirabegron, Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)
Nocturia Clinical Trial 2023: Brief Behavioral Treatment for Insomnia Highlights & Side Effects. Trial Name: NCT05604222 — Phase 4
Brief Behavioral Treatment for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05604222 — Phase 4
~57 spots leftby May 2026
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