The Patient-Centered Outcomes Research Institute (PCORI) plans to release a Targeted PCORI Funding Announcement on May 4, 2021, seeking to fund high-quality, comparative effectiveness research projects that focus on efficacious interventions for nonpregnant women with stress, urge, or mixed urinary incontinence (UI), addressing high-priority patient- and stakeholder-guided research questions. This preannouncement is provided to allow potential applicants additional time to identify collaborators; obtain stakeholder input on potential studies; and develop responsive, high-quality proposals.
Research Initiative Highlights
Although there is good evidence for the efficacy of many nonsurgical interventions for UI*, evidence gaps remain, particularly related to direct comparisons of the options. The full range of women affected by UI should be considered, although each application does not need to include all affected populations. If proposed studies include participants with more than one type of UI (stress, urge, or mixed), they should be adequately powered to detect differences by type. Study populations should include appropriate racial and ethnic diversity as well as those for whom access to care is a challenge.
PCORI will accept applications that propose rigorous randomized controlled trials or observational, prospective cohort studies. Applicants can propose to compare two or more of the nonsurgical treatment options for UI, including pharmacological, behavioral, lifestyle, and other nonpharmacological options. Alternative systems approaches that address some of the barriers and dissatisfaction around the various options previously described are also welcomed. Submitted proposals should evaluate both patient-centered functional and adverse outcomes. They may take place in care settings where women receive care for UI.
Applicants may request up to $5 million in direct costs for each project and a maximum study duration of five years. PCORI encourages study proposals with well-justified design and analysis plans that may be completed in a shorter time frame.
Deadline for Letter of Intent: June 1, 2021.
For this limited competition PFA, PCORI is soliciting applications from Prime organizations of Clinical Research Networks (CRNs) currently funded to participate in PCORnet. The Internal Revenue Service (IRS) must recognize all applicant organizations. Individuals are not permitted to apply.