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Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women (SLAB)

Primary Purpose

Urgency Urinary Incontinence, Nocturia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mirabegron 50 MG
Brief Behavioral Treatment for Insomnia
Sponsored by
Shachi Tyagi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urgency Urinary Incontinence

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: ambulatory women aged 60+ years urgency incontinence or urge-predominant mixed incontinence (able to differentiate between stress symptoms-cough, laugh, exercise-and leakage following the sudden onset of a strong urge to void that is difficult to defer during questioning on telephone screening) occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes nocturia ≥2 each night subjects with current or previous use of anticholinergic medications will be considered for the study if willing to go through a washout period of at least 4 weeks of duration Exclusion Criteria: contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics) cognitive impairment (MOCA score <24 or inability to accurately complete a voiding diary, perform a 24-hour pad test, reliably take daily medication, or comply with fMRI testing) prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation. spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer; multiple sclerosis urethral obstruction; urinary retention [PVR >200 ml] interstitial cystitis; artificial sphincter implant medical instability or expected change in medication during the study conditions that preclude fMRI testing, such as history of claustrophobia, history or suspicion of implanted metal or electronic object requirement for intravenous antibiotics for bacterial endocarditis prophylaxis or presence of multiple allergies to the antibiotics available in our protocol chronic or recurrent bowel issues, e.g. IBS, colitis, fecal incontinence known allergy to study medication or interaction with current medications severe uncontrolled hypertension >180 mmHg systolic or >100 mmHg diastolic

Sites / Locations

  • University of Pittsburgh
  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mirabegron

Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)

Arm Description

Mirabegron for 8 weeks

Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia

Outcomes

Primary Outcome Measures

Incontinence episodes
The number of incontinence episodes

Secondary Outcome Measures

Structural brain changes
Change in grey and white matter volume on MRI compared between the two arms. Grey matter and white matter volume of important brain structures will be compared via tractography.
Functional brain changes
Change in brain functional response to an infusion/withdrawal protocol compared between the two arms. Changes are displayed as a map of t-values for each voxel of the brain, showing likelihood of statistical significance of changes.
Nocturia episodes
The number of nocturia episodes

Full Information

First Posted
October 12, 2022
Last Updated
April 18, 2023
Sponsor
Shachi Tyagi
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05604222
Brief Title
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
Acronym
SLAB
Official Title
Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shachi Tyagi
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Urgency urinary incontinence (UUI), a form of overactive bladder (OAB), is prevalent (36% of women over age 65), morbid and costly ($83 billion/year), and treatment is problematic. Current treatment is largely bladder centric has limited efficacy,and adherence rates fade to 21% at 12 months. The researchers believe that a complimentary approach, one that also addresses etiology beyond the bladder may enhance treatment success. Up to 50% of older adults complain of poor sleep and nighttime bladder symptoms (nocturia) are considered the major cause. However, the relationship between sleep and the bladder is complex and bidirectional. Poor sleep not only exacerbates daytime lower urinary tract symptoms (LUTS), but can also cause these, increasing the risk of LUTS by up to 55% over 5 years. Sleep disruption increases anxiety and impairs daytime attention, both of which affect bladder control. Consistent with findings in anxiety disorders and attention control, poor sleep is linked to media prefrontal cortex (mPFC) hypoactivity, a region the investigators have identified as key to executive control of voiding and to therapeutic response to biofeedback-assisted pelvic floor muscle therapy. Hence, the investigators posit that enhanced mPFC function through improved sleep might ameliorate bladder control. Despite evidence of a bidirectional relationship, the impact of sleep treatment on UUI has never been assessed. The researchers prior study demonstrated that improving sleep using Brief Behavioral Treatment of Insomnia (BBTI), a simple intervention for insomnia, improved both sleep and nocturia in older adults, yet its impact on UUI and mechanism of action is not known. Our exploratory analysis of sleep and voiding data from 20 older adults with UUI and nocturia showed that with behavioral sleep intervention alone, 24-hour UUI episodes decreased with prolongation of uninterrupted sleep before the first awakening to void (r=-0.50, p=0.02), and increased proportion of deep sleep (r=-0.56, p=0.01). Hence, the researchers postulate that addressing sleep in patients with UUI and nocturia may further potentiate bladder-focused UUI treatment. The efficacy of mirabegron, a β3- adrenoceptor agonist is comparable to first-line antimuscarinic pharmacotherapy for UUI, with fewer side effects, but it has only a modest effect on nocturia. Although these drugs show statistically significant improvement in LUTS, drug compliance remains poor secondary to modest perceived clinical benefit. The researchers central hypothesis is that comorbid insomnia contributes to poor therapeutic response for UUI and concurrent insomnia treatment will improve outcomes. Specifically, addition of BBTI to drug therapy will improve sleep, nocturia, and daytime LUTS, likely mediated by improvement of mPFC function. The researchers propose an 8-week randomized controlled trial of mirabegron+BBTI vs. mirabegron alone for UUI in 100 women (aged ≥60), assessing both clinical and neural effects of treatment. The researchers will also assess durability of the combination therapy at 6 months. This design encompasses the role of sleep in OAB treatment, insight into the central and peripheral effects of mirabegron and BBTI, and response durability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urgency Urinary Incontinence, Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirabegron
Arm Type
Experimental
Arm Description
Mirabegron for 8 weeks
Arm Title
Mirabegron plus Brief Behavioral Treatment for Insomnia (BBTI)
Arm Type
Experimental
Arm Description
Mirabegron for 8 weeks and a 4 week behavioral intervention for insomnia
Intervention Type
Drug
Intervention Name(s)
Mirabegron 50 MG
Other Intervention Name(s)
Myrbetriq
Intervention Description
Medication to treat overactive bladder
Intervention Type
Behavioral
Intervention Name(s)
Brief Behavioral Treatment for Insomnia
Other Intervention Name(s)
BBTI
Intervention Description
A behavioral intervention for insomnia
Primary Outcome Measure Information:
Title
Incontinence episodes
Description
The number of incontinence episodes
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Structural brain changes
Description
Change in grey and white matter volume on MRI compared between the two arms. Grey matter and white matter volume of important brain structures will be compared via tractography.
Time Frame
Baseline to 8 weeks
Title
Functional brain changes
Description
Change in brain functional response to an infusion/withdrawal protocol compared between the two arms. Changes are displayed as a map of t-values for each voxel of the brain, showing likelihood of statistical significance of changes.
Time Frame
Baseline to 8 weeks
Title
Nocturia episodes
Description
The number of nocturia episodes
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Potential participants must be biologically female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ambulatory women aged 60+ years urgency incontinence or urge-predominant mixed incontinence (able to differentiate between stress symptoms-cough, laugh, exercise-and leakage following the sudden onset of a strong urge to void that is difficult to defer during questioning on telephone screening) occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes nocturia ≥2 each night subjects with current or previous use of anticholinergic medications will be considered for the study if willing to go through a washout period of at least 4 weeks of duration Exclusion Criteria: contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics) cognitive impairment (MOCA score <24 or inability to accurately complete a voiding diary, perform a 24-hour pad test, reliably take daily medication, or comply with fMRI testing) prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation. spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer; multiple sclerosis urethral obstruction; urinary retention [PVR >200 ml] interstitial cystitis; artificial sphincter implant medical instability or expected change in medication during the study conditions that preclude fMRI testing, such as history of claustrophobia, history or suspicion of implanted metal or electronic object requirement for intravenous antibiotics for bacterial endocarditis prophylaxis or presence of multiple allergies to the antibiotics available in our protocol chronic or recurrent bowel issues, e.g. IBS, colitis, fecal incontinence known allergy to study medication or interaction with current medications severe uncontrolled hypertension >180 mmHg systolic or >100 mmHg diastolic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shachi Tyagi, MD
Phone
412-647-1274
Email
tyagis@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shachi Tyagi, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shachi Tyagi, MD
Phone
412-647-1274
Email
tyagis@upmc.edu
First Name & Middle Initial & Last Name & Degree
Becky Clarkson, PhD
Phone
412-647-1270
Email
bdc29@pitt.edu
First Name & Middle Initial & Last Name & Degree
Daniel Buysse, MD
First Name & Middle Initial & Last Name & Degree
Becky Clarkson, PhD
First Name & Middle Initial & Last Name & Degree
Subashan Perera, PhD
First Name & Middle Initial & Last Name & Degree
Neil Resnick, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shachi Tyagi, MD, MS
Phone
412-647-1274
Email
sht55@pitt.edu
First Name & Middle Initial & Last Name & Degree
Kandy L Newell, RN
Phone
412.647.1271
Email
kln40@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification may be shared with other researchers.
IPD Sharing Time Frame
Following publication, no end date
IPD Sharing Access Criteria
Any purpose

Learn more about this trial

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

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