Urogynecology Device Coordinated Registry Network (UD CRN)

An initiative under the WHT CRN

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Background

The Urogynecology Device Coordinated Registry Network (UD CRN) will build on the work of the AUGS Community for Quality Improvement Using Real-world Evidence (ACQUIRE) formed in 2017 by the American Urogynecology Society (AUGS). ACQUIRE is a quality improvement initiative and safety surveillance registry that collects clinical, procedural and outcomes data at the time of surgery and for any subsequent interventions for US patients receiving surgical treatment for Stress Urinary Incontinence (SUI) or Prolapse (POP). ACQUIRE collects data from surgeons and their patients, which enables AUGS, urogynecologists, device manufacturers and other stakeholders to identify trends and important safety information.

ACQUIRE collaborates with device manufacturers that use the registry to further investigate device safety and improvement and includes utilization of the registry for device surveillance purposes required by the FDA.  ACQUIRE aims to fill the knowledge gap related to post market surveillance studies in the US and plans to expand globally in partnership with international registries.  In the future, the goal of the UD CRN is to use ACQUIRE data to study trends related to SUI and POP surgeries worldwide.

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Partnership Structure

UD CRN will be led by the UD CRN Leadership Committee of up to 6 people comprised of AUGS members in leadership positions within the society and as well as AUGS members that are actively participating in the ACQUIRE quality improvement program. The Leadership Committee will be responsible for developing and implementing the strategic goals of the UD CRN and will help guide registry operations, including the successful implementation, monitoring, and management of resources and activities.

The UD CRN will strongly encourage stakeholder engagement in this important area of women’s health through a Steering Committee made up of a broad, balanced group of up to 50 individuals. The UD CRN steering committee will include government agencies such as the FDA and professional societies like SGS, AAGL, SUFU, and MDEpiNet, as well as patient advocates and device manufacturers like Ethicon and UroCure.

The Steering Committee’s role includes helping to increase both physician and industry participation in ACQUIRE, identifying future needs and expansion opportunities, as well as openly discussing current challenges with the registry platform and engagement with physicians, patients and industry.

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Current Projects and Plans

​UD CRN’s current research projects include SUI surgery safety and outcome studies using the AUGS’ ACQUIRE registry platform and will expand to include POP studies in the near future.

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Longer Term Project Plans

The UD CRN intends to collaborate with several international SUI and POP registries to accelerate the ability to identify trends and safety concerns as well as variations in practice patterns, device usage, and outcomes by linking data from these sources. The collaborative effort will seek to standardize data elements and definitions to ensure that the data truly leads to real ‘world-wide” evidence that will benefit all patients.