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UNDERACTIVE BLADDER: EPIDEMIOLOGIC ANALYSES, SCREENER DEVELOPMENT AND VALIDATION

Award Number: U01DK110377
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2016
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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UNDERACTIVE BLADDER: EPIDEMIOLOGIC ANALYSES, SCREENER DEVELOPMENT AND VALIDATION - PROJECT SUMMARY/ABSTRACT While the overactive bladder (OAB) is a well-researched and common urologic condition, its apparent opposite, the underactive bladder (UAB), remains neglected and poorly understood. UAB is increasingly recognized as a likely cause of lower urinary tract symptoms (LUTS), is commonly encountered in clinical practice, and severely impacts a patient's quality of life. If undiagnosed and untreated, UAB can lead to significant morbidity and may be life threatening. Epidemiologic research is considered a necessary step towards development of promising treatment modalities, but the present state of this research has been characterized as “rudimentary”. The underlying pathophysiology of UAB remains poorly understood and its objective characterization uncertain. To begin to fill knowledge gaps surrounding UAB we propose research with two logically related phases: During Phase l we will complete focused statistical/epidemiologic analyses which cost-efficiently employ data from a large internationally respected urologic cohort study—the Boston Area Community Health (BACH) survey. These analyses will focus on the hypothesized and pathophysiologically plausible association of a range of potential risk factors with suspected symptomatic UAB: data on numerous factors are already available and grouped into conceptually distinct domains (socio-demographic, anthropometric/life events, nutrition, comorbidities, surgical interventions and medications). Because of likely gender-specific phenotypes we will consider symptomatic UAB separately in women and men. We will also examine unmet UAB need, how UAB overlaps with other urologic symptoms and whether UAB is predictive of (a sentinel event for) subsequent disease. Phase ll logically follows with the construction and clinical validation of a brief self- administered multidimensional UAB risk assessment tool, which will integrate clinically informative factors from both phases. Scale development and validation have been planned in detail and include item development and cognitive testing, and formal psychometric assessment, including scoring guidelines and validated diagnostic cutpoints for UAB. Upon completion of both phases (epidemiologic analyses and validated UAB screener development) we will publish results in top tier professional journals (to gain scientific acceptability) and present results at major clinical meetings (to gain clinical acceptability). In the age of online health information seeking, patient empowerment and shared decision making, this evidence-based tool will provide at-risk UAB patients useful information to trigger primary care providers and urologists towards more appropriate diagnosis and effective management of UAB. The tool will also provide a means to cost-efficiently prescreen potentially eligible UAB patients for future RCTs of promising interventions.


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: 2023 ( Subtotal = -$34,515 )
2023	2019	NEW ENGLAND RESEARCH INSTITUTES INC	220 VIRGINIA AVE	INDIANAPOLIS	IN	46204	MARION	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/20/2023	SUPPLEMENT FOR EXPANSION	-$34,515
														Subtotal = -$34,515

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/5/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/6/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	5/7/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/22/2020	NON-COMPETING CONTINUATION	$0
2020	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/8/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $97,644 )
2019	2019	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	8/26/2019	SUPPLEMENT FOR EXPANSION	$97,644
2019	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/11/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $97,644

Issue Date FY: 2018 ( Subtotal = $686,529 )
2018	2018	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	8/22/2018	NON-COMPETING CONTINUATION	$686,529
														Subtotal = $686,529

Issue Date FY: 2017 ( Subtotal = $685,167 )
2017	2017	NEW ENGLAND RESEARCH INSTITUTES, INC.	480 PLEASANT STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/22/2017	NON-COMPETING CONTINUATION	$685,167
														Subtotal = $685,167

Issue Date FY: 2016 ( Subtotal = $688,461 )
2016	2016	NEW ENGLAND RESEARCH INSTITUTE, INC	9 GALEN STREET	WATERTOWN	MA	02472	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/12/2016	NEW	$688,461
														Subtotal = $688,461

Grand Total All Awards = $2,123,286

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UNDERACTIVE BLADDER: EPIDEMIOLOGIC ANALYSES, SCREENER DEVELOPMENT AND VALIDATION

Award Number: U01DK110377

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2016

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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