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Neurourol Urodyn. 2017 Apr;36(4):1178-1186. doi: 10.1002/nau.23091. Epub 2016 Sep 21.

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 information

1
Catholic University, Rome, Italy.
2
G. Fornaroli Hospital, Magenta (MI), Italy.
3
SS. Annunziata Hospital, Chieti-Pescara, Italy.
4
IRCCS, San Matteo Hospital, Pavia, Italy.
5
S. Maria degli Angeli Hospital, Pordenone, Italy.
6
CTO-Maria Adelaide Hospital, Turin, Italy.
7
R&D Department, IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
8
CeRGAS Bocconi, Milan, Italy.
9
Medical Oncology Department, Mirano Hospital, Mirano (VE), Italy.

Abstract

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.

KEYWORDS:

DMSO; Ialuril; bladder pain syndrome; chondroitin sulfate; hyaluronic acid; interstitial cystitis

PMID:
27654012
DOI:
10.1002/nau.23091
[Indexed for MEDLINE]

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