Efficacy of intravesical chondroitin sulphate in treatment of interstitial cystitis/bladder pain syndrome (IC/BPS): Individual patient data (IPD) meta-analytical approach

Background: Raw data from 3 similar clinical trials were analyzed in this individual participant data (IPD) meta-analysis to define any possible efficacy of intravesical 2% chondroitin sulphate in IC/BPS. Methods: We pooled IPD from an open label and 2 small randomized placebo controlled trials assessing chondroitin sulphate in IC/BPS (similar inclusion/exclusion criteria, treatment, outcome assessment). Our primary objective was to compare rates of global response assessment (GRA) responsiveness between chondroitin sulphate and vehicle control. Secondary objectives compared the Interstitial Cystitis Symptom/Problem Index (ICSI/PI) total score and improvement rates, and average daily urine frequency. The treatment response was calculated for individual trials and pooled data using IPD meta-analysis for pooling proportions. Results: In total, 213 patients were included in the pooling analysis. At the end of the treatment period, the overall GRA response rates were 43.2 (95% CI: 35.0, 51.5) and 27.4 (95% CI: 17.6, 37.2) for the chondroitin sulphate and vehicle control groups, respectively. Pooled RR was 1.55 (p = 0.014, 95% CI: 1.09, 2.22). The chance of being an ICSI responder was similarly 54% higher in the chondroitin sulphate group. The small decrease in total ICSI score and urine frequency between the two groups was less impressive (-0.8 and -0.5 points respectively) and not statistically significant. Conclusions: Benefits from intravesical chondroitin sulphate treatment in IC/BPS patients can be confirmed by increasing the power of the available data using an IPD meta-analytical approach. However, disconnect between response rates and severity scores underline the importance of choosing the right patient for this organ-specific treatment.