Journal article
Widespread pain phenotypes impact treatment efficacy results in randomized clinical trials for interstitial cystitis/bladder pain syndrome: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain network study
Pain (Amsterdam), Vol.166(5), pp.1179-1190
05/2025
DOI: 10.1097/j.pain.0000000000003455
PMCID: PMC12004979
PMID: 39499552
Abstract
Abstract Pain clinical trials are notoriously complex and often inefficient in demonstrating efficacy, even for known efficacious treatments. A major issue is the difficulty in the a priori identification of specific phenotypes to include in the study population. Recent work has identified the extent of widespread pain as an important determinant of the likelihood of response to therapy, but it has not been tested in clinical trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). We explored this hypothesis using data from 3 previously published trials testing treatments for IC/BPS, which suggested modest benefits but did not meet a priori primary outcome statistical significance criteria. Importantly, these studies also collected symptom questionnaire data that allowed us to retrospectively identify participants with and without widespread pain. Analyzing the treatment by the degree of widespread pain revealed a difference in outcome and statistical significance level for each trial. Participants with predominately local pain (ie, limited widespread pain symptoms) responded to therapy targeting local symptoms, whereas those with widespread pain did not. Alternatively, participants with widespread pain beyond their local pelvic pain responded to more centrally acting treatments. Our results suggest that differentiating patients based on widespread vs more localized pain is a key consideration for designing future clinical trials for conditions with variable pain profiles, such as IC/BPS and potentially other pain-based syndromic disorders.
Details
- Title: Subtitle
- Widespread pain phenotypes impact treatment efficacy results in randomized clinical trials for interstitial cystitis/bladder pain syndrome: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain network study
- Creators
- John T. Farrar - University of PennsylvaniaKenneth T. Locke - University of PennsylvaniaJ. Quentin Clemens - University of MichiganJames W. Griffith - Northwestern UniversitySteven E. Harte - University of MichiganZiya Kirkali - National Institute of Diabetes and Digestive and Kidney DiseasesKarl J. Kreder - University of IowaJohn N. Krieger - University of WashingtonH. Henry Lai - Washington University in St. LouisRobert M. Moldwin - Donald & Barbara Zucker School of Medicine at Hofstra/NorthwellChris Mullins - National Institute of Diabetes and Digestive and Kidney DiseasesBruce D. Naliboff - University of California, Los AngelesMichel A. Pontari - Temple UniversityLarissa V. Rodríguez - Penn Presbyterian Medical CenterAnthony J. Schaeffer - Northwestern UniversityAndrew Schrepf - University of MichiganAlisa Stephens-Shields - University of PennsylvaniaSiobhan Sutcliffe - Washington University in St. LouisBayley J. Taple - Northwestern UniversityDavid A. Williams - University of MichiganJ. Richard Landis - University of Pennsylvania
- Resource Type
- Journal article
- Publication Details
- Pain (Amsterdam), Vol.166(5), pp.1179-1190
- DOI
- 10.1097/j.pain.0000000000003455
- PMID
- 39499552
- PMCID
- PMC12004979
- NLM abbreviation
- Pain
- ISSN
- 0304-3959
- eISSN
- 1872-6623
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- Grant note
- National Institute of Diabetes and Digestive and Kidney Diseases: U24-DK082316 National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
This project was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health Grant U24-DK082316.
- Language
- English
- Electronic publication date
- 11/05/2024
- Date published
- 05/2025
- Academic Unit
- Obstetrics and Gynecology; Urology
- Record Identifier
- 9984740872402771
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