Nonsurgical Options for Women with Urinary Incontinence -- Cycle 2 2021

This targeted PCORI Funding Announcement (tPFA) seeks 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. 

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.  

*See the recently updated systematic evidence review, supported by PCORI through a research partnership with the Agency for Healthcare Research and Quality (AHRQ). Note that AHRQ and PCORI, in collaboration, have both initiated implementation funding initiatives to promote improved, evidence-based care for UI reflecting the findings from this body of evidence. Findings from this upcoming targeted research funding opportunity should further advance care options for this highly prevalent condition.