Tuesday, July 1, 2025 7/1/2025

Sleep and Bladder Study

Award Number: R01AG076575
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Sleep and Bladder Study - PROJECT SUMMARY Prevalent, morbid, and costly (≥$83 billion/year), urgency urinary incontinence (UUI) is a major problem, especially for older women. With etiology usually ascribed to bladder spasms, the available therapies are bladder-targeted and provide only a modest benefit. Despite inadequate response and poor adherence, there has been little change in therapeutic approach to UUI in decades, and a novel holistic approach to complement or enhance current treatment will have a significant impact on care of those with the debilitating symptoms. UUI has strong bidirectional relationship with poor sleep, a prevalent complaint in older adults. Up to 50% of older adults report poor sleep, which increases the risk of UUI by up to 55% over 5 years. The brain plays a vital role in the continence mechanism and sleep is known to affect the pathways involved in executive continence control. Specifically, sleep loss is associated with hypoactivity in the medial prefrontal cortex (mPFC) – a region we have identified to be involved in executive control of voiding, and potential therapeutic response to biofeedback-assisted pelvic floor muscle therapy. Hence, we hypothesize that poor sleep inhibits bladder control as it does with cognitive tasks; and addressing sleep will improve executive control of the bladder complementing concurrent bladder-targeted UUI therapy. Our overall goals are to: (a) assess the additional benefit of behavioral sleep intervention on UUI to the standard of care (β3- adrenoceptor agonist mirabegron) providing evidence for assessing and addressing sleep for treatment of UUI, and (b) better understand the brain’s role in the effect of sleep on UU providing rationale to investigate other ameliorative brain-based therapies targeting the identified brain pathways. Specific aims are to examine the effect of adjunctive Brief Behavioral Treatment of Insomnia (BBTI) with the first-line pharmacotherapy: mirabegron on (1) UUI; (2) nocturia; (3) mPFC activity to confirm therapeutic mechanisms by assessing the effect of sleep on currently understood mediators; and (4) durability of therapeutic response. We will randomize 100 women aged ≥ 60 years to receive 8 weeks of either mirabegron alone or mirabegron+BBTI, assessing bladder symptoms, sleep, and functional and structural brain changes pre- and post-intervention. We will also explore the durability of therapeutic response at 6-months post-intervention. The study will provide the first-ever data on a comprehensive multicomponent brain-bladder therapy for incontinence targeting the known brain mechanisms involve in continence control. It will evaluate clinical response and durability of this novel pairing and provide an understanding of the underlying pathways involved in its therapeutic mechanism.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $448,524 )
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	000	4	4/30/2025	NON-COMPETING CONTINUATION	$411,910
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	001	4	6/20/2025	NON-COMPETING CONTINUATION	$36,614
														Subtotal = $448,524

Issue Date FY: 2024 ( Subtotal = $456,832 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	000	3	4/17/2024	NON-COMPETING CONTINUATION	$456,832
														Subtotal = $456,832

Issue Date FY: 2023 ( Subtotal = $474,065 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	001	2	5/5/2023	NON-COMPETING CONTINUATION	$474,065
2023	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	000	1	11/9/2022	NEW	$0
														Subtotal = $474,065

Issue Date FY: 2022 ( Subtotal = $449,519 )
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Aging Research	000	1	7/27/2022	NEW	$449,519
														Subtotal = $449,519

Grand Total All Awards = $1,828,940

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Sleep and Bladder Study

Award Number: R01AG076575

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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