Lack of standardized diagnostic criteria for IC/BPS hinders research progress in understanding its risk factors, pathogenesis, prognosis, and treatment. Emerging evidence suggests that urinary and serum biomarkers may play a crucial role in the diagnosis and treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). 
The first aim was to evaluate the correlation between cystoscopic, histopathological, molecular, and clinical data in women with IC/BPS. The secondary aim was to compare clinical and diagnostic data between IC/BPS patients and a control group.

This is an observational multicenter prospective pilot study. Preoperative workup includes medical history, physical exam, urodynamic studies, urine/serum sampling, cystoscopy with hydrodistension and biopsies. Analysis of accuracy of biomarkers was determined using area under the receiver operator characteristics curve (AUC). Statistical significance was set at p<0.05 (95% confidence interval). Statistical analysis was performed using the SPSS Version 26.0 for Windows (SPSS Statistics UK, SPSS Inc, Chicago, IL, USA).

Between January 2022 and June 2024 30 patients were included in the study, 15 in the IC/BPS group and 15 in the control group. IC/BPS women exhibited lower bladder capacity and increased bladder sensitivity compared to controls. IC/BPS patients experienced premature filling sensations and reduced bladder capacity compared to controls. Women with lower urodynamic first desire to void (FD) had a significative higher possibility to have IC/BPS (RR 7.161, p=0.007). No significant differences were found in bladder biopsies between non-HL-IC/BPS and control groups. Four urinary metabolic analytes were identified as potential biomarkers for differentiating IC/BPS from N IC/BPS: Alpha amino butyric acid, histidine, leucine and valine were significantly higher in IC/BPS patients and had individual AUCs greater than 0.8. When combined into a single model, the AUC was 0.917, demonstrating its high sensitivity and specificity.

Our preliminary study underlines the importance of urodynamic testing and the significant role of specific questionnaires together with the personal history in the diagnosis of IC/BPS.
Cystoscopyc bladder biopsies don’t differentiate IC/BPS from other similar diseases. Data from this pilot study strongly suggest urine as a potential resource for clinical screening of women with IC/BPS.

To our knowledge, this is the first Italian study investigating both traditional and experimental diagnostic tools for IC/BPS, including a control cohort. If we also consider the biomarker panel identified in this study, we can imagine how these results, if validated by larger multicenter studies, may have a profound effect on the diagnostic process of IC/BPS.

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