# Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome

> **NIH NIH R01** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $734,798

## Abstract

ABSTRACT:
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating chronic condition characterized by pain,
pressure, and discomfort in the pelvic region coupled with urinary symptoms. The pain involved in IC/BPS can
be debilitating and is incurable. As it stands, many of the available treatments for IC/BPS lack strong evidence
for their use and are costly to patients. Further, patients report significant dissatisfaction with medical care,
describing treatments as “trial-and-error," expensive, and having “fragmented” treatment plans to follow.
Treatment advances in IC/BPS have stalled due to a lack of clear understanding of the condition, as symptoms
and presentations vary widely. For these reasons, national organizations have prioritized the need to improve
both treatment options and understanding of IC/BPS. Leading multi-institutional research networks have now
identified that individuals with IC/BPS have distinct subgroups, or “phenotypes,” largely characterized by the
distribution of pain throughout the body. These presentations of IC/BPS have distinct clinical and
neurobiological features. Specifically, while a proportion of individuals with IC/BPS have symptoms primarily in
the pelvic region (“peripheral” phenotype), others experience additional pain outside of the pelvis coupled with
unrefreshing sleep, cognitive dysfunction, emotional distress, and energy depletion (“centralized” phenotype).
In terms of neurobiological features, individuals with “centralized” presentations also exhibit exaggerated
inflammatory responses to ex vivo stimulation and heightened responses to evoked pain. Supported by our
preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response
to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and
cognitive-behavioral therapy (CBT) for IC/BPS. We hypothesize that we can predict those who will respond
preferentially to either form of treatment based on reported bodily pain distribution (pelvic pain primarily, pain
outside of the pelvis). We are proposing a randomized mechanistic trial to evaluate which participants may
benefit from each treatment (Aim 1) and evaluate whether neurobiological mechanisms may moderate
outcomes and change with treatment (Aim 2). Per an individual’s reported level of baseline widespread pain,
we will randomize 220 participants to receive either 8-weeks of CBT or 10-weeks of PT. Participants will
receive three assessments throughout, [before, after, and at 6- months]. Assessments include patient-reported
outcomes, biological markers of inflammation, and psychophysical testing [taken at each timepoint]. This
project has great potential to tailor treatment and improve future IC/BPS precision-medicine care efforts.

## Key facts

- **NIH application ID:** 10837078
- **Project number:** 5R01DK133415-02
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Lindsey Colman McKernan
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $734,798
- **Award type:** 5
- **Project period:** 2023-05-05 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837078

## Citation

> US National Institutes of Health, RePORTER application 10837078, Mechanistic-Based Treatment of Interstitial Cystitis/Bladder Pain Syndrome (5R01DK133415-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10837078. Licensed CC0.

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