A prospective randomized controlled multicentre trial comparing intravesical DMSO and chondroïtin sulphate 2% for painful bladder syndrome/interstitial cystitis

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Vol. 43 (1): 134-141, January – February, 2017

doi: 10.1590/S1677-5538.IBJU.2016.0302


ORIGINAL ARTICLE

Manuela Tutolo 1, Enrico Ammirati 2, Giulia Castagna 3, Katrien Klockaerts 4, Hendrik Plancke 5, Dieter Ost 6, Frank Van der Aa 1, Dirk De Ridder 1

1 Department of Urology, University Hospitals, KU Leuven, Belgium; 2 Division of Urology, Città della Salute e della Scienza, Molinette Hospital Hospital, University of Studies of Turin, Turin, Italy; 3 Department of Urological Research Institute, IRCCS Ospedale San Raffaele, Division of Oncology/Unit of Urology, Milan, Italy; 4 Department of Urology, St. Lucas Hospital, Gent, Belgium; 5 Department of Urology, Imelda Hospital, Bonheiden, Belgium; 6 Urology, St. Blasius Hospital, Dendermonde, Belgium

ABSTRACT

Objective: To compare effectiveness of intravesical chondroïtin sulphate (CS) 2% and dimethyl sulphoxide (DMSO) 50% in patients with painful bladder syndrome/intersti­tial cystitis (PBS/IC).

Materials and methods: Patients were randomized to receive either 6 weekly instil­lations of CS 2% or 50% DMSO. Primary endpoint was difference in proportion of patients achieving score 6 (moderately improved) or 7 (markedly improved) in both groups using the Global Response Assessment (GRA) scale. Secondary parameters were mean 24-hours frequency and nocturia on a 3-day micturition dairy, changes from baseline in O’Leary-Sant questionnaire score and visual analog scale (VAS) for supra­pubic pain.

Results: Thirty-six patients were the intention to treat population (22 in CS and 14 in DMSO group). In DMSO group, 57% withdrew consent and only 6 concluded the trial. Major reasons were pain during and after instillation, intolerable garlic odor and lack of efficacy. In CS group, 27% withdrew consent. Compared with DMSO group, more patients in CS group (72.7% vs. 14%) reported moderate or marked improvement (P=0.002, 95% CI 0.05-0.72) and achieved a reduction in VAS scores (20% vs. 8.3%). CS group performed significantly better in pain reduction (-1.2 vs. -0.6) and nocturia (-2.4 vs. -0.7) and better in total O’Leary reduction (-9.8 vs. -7.2). CS was better toler­ated. The trial was stopped due to high number of drop-outs with DMSO.

Conclusions: Intravesical CS 2% is viable treatment for PBS/IC with minimal side ef­fects. DMSO should be used with caution and with active monitoring of side effects. More randomized controlled studies on intravesical treatments are needed.

Keywords:  Cystitis, Interstitial; Dimethyl Sulfoxide; Chondroitin Sulfates

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