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Phenotype Variability in Interstitial Cystitis Clinical Trial Recruitment
Journal article   Peer reviewed

Phenotype Variability in Interstitial Cystitis Clinical Trial Recruitment

Ryan Wong, Emmaline Woodworth, Charles Wood, Sarah A Adelstein and Annah J Vollstedt
Urogynecology, Vol.32(8), pp.928-933
08/2026
DOI: 10.1097/SPV.0000000000001759
PMID: 41025942

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Abstract

There is a need to understand phenotype-specific therapies for interstitial cystitis/bladder pain syndrome (IC/BPS) at the clinical trial level to move beyond trial-and-error treatment approaches. The objective of this study was to characterize IC/BPS clinical trials that incorporate patient phenotype into the eligibility criteria in accordance with the American Urological Association (AUA) guidelines. Registered IC/BPS clinical trials were identified from ClinicalTrials.gov. Trials were included if they enrolled patients with IC/BPS and addressed pain-related outcomes. Trials were assessed for phenotype recognition and categorized by intervention type, funding source, and registration date relative to the AUA's 2015 IC/BPS guidelines for initial phenotype recognition. Out of 170 trials, 37 (21.8%) included phenotype stratification. The majority focused on bladder-centric presentations. Men were underrepresented in IC/BPS clinical trials. Phenotypic stratification was more frequently reported in industry-funded trials compared with those without industry support (40.5% vs 16.5%, P=0.0031). Trials registered after the 2015 AUA guideline update showed greater phenotype inclusion, though this was not statistically significant (26.6% vs 15.8%). Therapeutic trials comprised the majority of trials. Stratification appeared more often in physical therapy and psychosocial trials at 40% and in drug studies at 34.3%. Intravesical instillation and injection trials showed lower rates at 19.6% and 13.0%, respectively. Failure to incorporate IC/BPS phenotypes into trial design limits the ability to evaluate treatments within the context of real-world symptom variability. Bridging this methodological gap is essential to ensure that clinical research supports the development of more targeted and effective therapies.

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