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Overcoming complications of polypropylene prolapse meshes: Development of novel elastomeric membranes

Award Number: R01HD097187
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/30/2025
PERIOD OF PERFORMANCE END DATE: 04/30/2030

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Overcoming complications of polypropylene prolapse meshes: Development of novel elastomeric membranes - PROJECT SUMMARY Pelvic organ prolapse (POP) is a common, costly condition in women with a lifetime risk of surgical repair of 12.6%. Of those undergoing a native tissue repair, 70% will fail by 5 years prompting surgeons to turn to biomaterials, most commonly polypropylene mesh (PPM). Unfortunately, POP meshes were never designed specifically for the vagina and are hampered by complications. Our studies show that implantation of PPM leads to degeneration, atrophy, and loss of function of the vagina. The high material stiffness of polypropylene dictates that meshes manufactured from this polymer are knitted, leading to a device that undergoes pore collapse, wrinkling, and permanent deformation upon tensioning. These changes result in an increased mesh burden, a heightened foreign body response, and poor outcomes. To overcome the limitations of current PPMs, we have manufactured an elastomeric membrane (EM) from polycarbonate urethane (PCU) for use in POP repair surgeries. The EMs are 3D printed (to afford rapid prototyping) with a material stiffness that is on the same order of magnitude as that of the vagina, a geometry that favors stable pores, and minimal wrinkling with tensioning. In vivo assessment of physicochemical properties of small EM constructs (2x1cm2) demonstrated a markedly improved host response as compared to similarly sized PPMs. In this renewal application, we propose to expand our in vivo evaluation to full length EMs in a nonhuman primate POP repair model (sacrocolpopexy) and to improve our product based on potential limitations. First, softer devices, while better for host response, can lead to surgical failure under lower loads, necessitating thicker devices or devices that are spatially graded to provide increased mechanical support in certain locations such as mesh anchor points. Second, our current EMs do not bioactively interact with the vagina which is compromised in individuals with POP. To address these issues, we propose to develop the next generation of mechanically graded and functionally interactive EMs, hypothesizing they will improve long-term tissue viability and reduce the host response to the implanted device. We test this hypothesis in 3 aims. In Aim 1, we develop tunable membranes that are mechanically graded with less material over the vagina and increased material in stem that forms a bridge to the sacrum. This design feature will decrease risk of failure at the sacrum and in the bridge and facilitate tacking or sewing into the device without negatively impacting the vaginal host response. In Aim 2, we take advantage of our expertise in polymer synthesis to develop an EM that is functionalized with synthetic peptides designed to promote interaction/integration into the host extracellular matrix and to overcome some of the negative impacts of biomaterials on host tissues. In both Aims 1 and 2, we evaluate the host response in vivo to the small EM constructs using a rabbit vaginal implantation model. In Aim 3, we implant the final iterations of the EM prototypes developed in this and our previous application in a nonhuman primate prolapse repair model for a final preclinical assessment. We look forward to this opportunity to improve outcomes for women with POP.


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: 2026 ( Subtotal = $678,530 )
2026	2026	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	7	4/2/2026	NON-COMPETING CONTINUATION	$678,530
														Subtotal = $678,530

Issue Date FY: 2025 ( Subtotal = $728,997 )
2025	2025	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	6	7/30/2025	COMPETING CONTINUATION	$728,997
2025	2023	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	001	5	8/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $728,997

Issue Date FY: 2023 ( Subtotal = $452,703 )
2023	2023	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	002	5	4/12/2023	NON-COMPETING CONTINUATION	$452,703
2023	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	4	10/28/2022	NON-COMPETING CONTINUATION	$0
2023	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	001	4	12/16/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $452,703

Issue Date FY: 2022 ( Subtotal = $499,088 )
2022	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	4	4/23/2022	NON-COMPETING CONTINUATION	$499,088
														Subtotal = $499,088

Issue Date FY: 2021 ( Subtotal = $517,640 )
2021	2021	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	3	3/15/2021	NON-COMPETING CONTINUATION	$517,640
														Subtotal = $517,640

Issue Date FY: 2020 ( Subtotal = $527,629 )
2020	2020	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	2	3/31/2020	NON-COMPETING CONTINUATION	$527,629
														Subtotal = $527,629

Issue Date FY: 2019 ( Subtotal = $542,271 )
2019	2019	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Child Health and Human Development Extramural Research	000	1	4/17/2019	NEW	$542,271
														Subtotal = $542,271

Grand Total All Awards = $3,946,858

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Overcoming complications of polypropylene prolapse meshes: Development of novel elastomeric membranes

Award Number: R01HD097187

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/30/2025

PERIOD OF PERFORMANCE END DATE: 04/30/2030

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