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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
Author(s) -
Cervigni Mauro,
Sommariva Monica,
Tenaglia Raffaele,
Porru Daniele,
Ostardo Edoardo,
Giammò Alessandro,
Trevisan Silvia,
Frangione Valeria,
Ciani Oriana,
Tarricone Rosanna,
Pappagallo Giovanni L.
Publication year - 2017
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23091
Subject(s) - interstitial cystitis , medicine , hyaluronic acid , bladder pain syndrome , urology , chondroitin sulfate , dimethyl sulfoxide , open label , randomized controlled trial , urinary system , chemistry , organic chemistry , anatomy , glycosaminoglycan
AIMS 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). METHODS 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. RESULTS 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. CONCLUSIONS 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.