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Fecobionics monitoring and prediction of biofeedback therapy outcome in patients with obstructed defecation.

Award Number: R01DK134689
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Fecobionics monitoring and prediction of biofeedback therapy outcome in patients with obstructed defecation. - ABSTRACT Defecatory disorders affect 25% of the population and they are poorly recognized and treated. The incidence of defecatory disorders including chronic constipation is rising and it poses a major healthcare burden. The underlying mechanisms for these disorders are often not well understood. Obstructed defecation (dyssynergia) has several causes and is subdivided in four subtypes. Despite the high prevalence and incidence, diagnostics and treatment options are sparse. A significant problem in anorectal physiology testing is a lack of physiologically relevant and practical diagnostic test for identifying the underlying mechanisms to identify proper treatment. Current diagnostic tests provide incomplete and often conflicting information because they do not simulate feces or the defecation process. Not surprisingly, results of these tests correlate poorly with symptoms and treatment outcomes. Biofeedback therapy is a well-established therapy for obstructed defecation but despite the substantial potential and promising results, biofeedback therapy is only done at specialized centers and should be advanced closer to the point of care. The objective of this small R01 proposal is to monitor and predict the outcome of biofeedback therapy based on unprecedented integrated visual feedback from the novel simulated feces device termed Fecobionics. The device is electronic simulated feces that has the consistency and shape of normal stool. Fecobionics will provide mechanistic understanding of defecation for the examiner by visualizing the geometric (cross-sectional area, bending and shape of device) and manometric profiles of the simulated feces before and during defecation. The central hypothesis is that the Fecobionics device that mimics natural dynamic defecation provides valid data on rectal emptying attempts for the various components of the defecatory system such as the tone of anal sphincters and puborectalis muscle, and on mechanosensory properties. The objective is to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data that can be visualized during anorectal neuromuscular exercises. For the proposed studies, we will select dyssynergia patients, who will be monitored with Fecobionics before, during and after biofeedback therapy. The hypothesis is Fecobionics data will correlate better to symptoms based on constipation scores than conventional technologies and that such data can be used to predict responders and non-responders to therapy. Our proposal seeks to shift current research in constipation therapy by use of a novel device that provides mechanistic insights by simulating defecation pathophysiologically and examining the mechanistic changes multi-dimensionally: Pressure, deformability, biomechanics, and topographic changes to monitor underlying defects in patients with obstructed defecation, especially in dyssynergia. The unique aspects of our proposal are to simulate stool with a bionics device that integrates multiple variables that examine the mechanistic underpinnings of obstructed defecation. The impact of this project is to shed new understanding of constipation and to predict responders. This will facilitate development of innovative bowel management programs using Fecobionics as the biofeedback therapy tool.


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 = $370,000 )
2025	2025	THE CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC	11107 ROSELLE ST STE 211	SAN DIEGO	IN	92121		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/28/2025	NON-COMPETING CONTINUATION	$370,000
														Subtotal = $370,000

Issue Date FY: 2024 ( Subtotal = $355,200 )
2024	2024	THE CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC	11107 ROSELLE ST STE 211	SAN DIEGO	IN	92121		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	3/21/2024	NON-COMPETING CONTINUATION	$333,000
2024	2024	THE CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC	11107 ROSELLE ST STE 211	SAN DIEGO	IN	92121		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/20/2024	NON-COMPETING CONTINUATION	$22,200
														Subtotal = $355,200

Issue Date FY: 2023 ( Subtotal = $370,000 )
2023	2023	CALIFORNIA MEDICAL INNOVATIONS INSTITUTE STE	11107 ROSELLE ST	SAN DIEGO	CA	92121	SAN DIEGO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/24/2023	NEW	$370,000
														Subtotal = $370,000

Grand Total All Awards = $1,095,200

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Fecobionics monitoring and prediction of biofeedback therapy outcome in patients with obstructed defecation.

Award Number: R01DK134689

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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