A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis

Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril(®) , IBSA) to dimethyl sulfoxide (DMSO).

Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses.

A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735€/quality-adjusted life years (QALY) and 8003€/QALY.

Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile.

Neurourology and urodynamics. 2016 Sep 21 [Epub ahead of print]

Mauro Cervigni, Monica Sommariva, Raffaele Tenaglia, Daniele Porru, Edoardo Ostardo, Alessandro Giammò, Silvia Trevisan, Valeria Frangione, Oriana Ciani, Rosanna Tarricone, Giovanni L Pappagallo

Catholic University, Rome, Italy. ., G. Fornaroli Hospital, Magenta (MI), Italy., SS. Annunziata Hospital, Chieti-Pescara, Italy., IRCCS, San Matteo Hospital, Pavia, Italy., S. Maria degli Angeli Hospital, Pordenone, Italy., CTO-Maria Adelaide Hospital, Turin, Italy., R&D Department, IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland., CeRGAS Bocconi, Milan, Italy., Medical Oncology Department, Mirano Hospital, Mirano (VE), Italy.