title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Catholic University, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Cervigni
authors.affiliation: G. Fornaroli Hospital, Magenta (MI), Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Sommariva
authors.affiliation: SS. Annunziata Hospital, Chieti-Pescara, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Tenaglia
authors.affiliation: IRCCS, San Matteo Hospital, Pavia, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Porru
authors.affiliation: S. Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Ostardo
authors.affiliation: CTO-Maria Adelaide Hospital, Turin, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Giammò
authors.affiliation: R&D Department, IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
authors.forename: Silvia
authors.initials: S
authors.lastname: Trevisan
authors.affiliation: R&D Department, IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
authors.forename: Valeria
authors.initials: V
authors.lastname: Frangione
authors.affiliation: CeRGAS Bocconi, Milan, Italy.
authors.forename: Oriana
authors.initials: O
authors.lastname: Ciani
authors.affiliation: CeRGAS Bocconi, Milan, Italy.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Tarricone
authors.affiliation: Medical Oncology Department, Mirano Hospital, Mirano (VE), Italy.
authors.forename: Giovanni L
authors.initials: GL
authors.lastname: Pappagallo
mesh_terms: D000283:Administration, Intravesical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002809:Chondroitin Sulfates / Q000008:administration & dosage* / Q000191:economics; D003362:Cost-Benefit Analysis; D018856:Cystitis, Interstitial / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D004121:Dimethyl Sulfoxide / Q000008:administration & dosage* / Q000191:economics; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000191:economics; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D011788:Quality of Life; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects; D064804:Urological Agents / Q000008:administration & dosage* / Q000191:economics; D055815:Young Adult
chemical_list: D064804:Urological Agents; D006820:Hyaluronic Acid; D002809:Chondroitin Sulfates; D004121:Dimethyl Sulfoxide
keywords: DMSO; Ialuril; bladder pain syndrome; chondroitin sulfate; hyaluronic acid; interstitial cystitis