To compare effectiveness of intravesical chondroïtin sulphate (CS) 2% and dimethyl sulphoxide (DMSO) 50% in patients with painful bladder syndrome/interstitial cystitis (PBS/IC).
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.
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.
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.
International braz j urol : official journal of the Brazilian Society of Urology. 0000 Jan [Epub]
Manuela Tutolo, Enrico Ammirati, Giulia Castagna, Katrien Klockaerts, Hendrik Plancke, Dieter Ost, Frank Van der Aa, Dirk De Ridder
Department of Urology, University Hospitals, KU Leuven, Belgium., Division of Urology, Città della Salute e della Scienza, Molinette Hospital Hospital, University of Studies of Turin, Turin, Italy., Department of Urological Research Institute, IRCCS Ospedale San Raffaele, Division of Oncology/Unit of Urology, Milan, Italy., Department of Urology, St. Lucas Hospital, Gent, Belgium., Department of Urology, Imelda Hospital, Bonheiden, Belgium., Urology, St. Blasius Hospital, Dendermonde, Belgium.