title: A prospective randomized controlled multicentre trial comparing intravesical DMSO and chondroïtin sulphate 2% for painful bladder syndrome/interstitial cystitis.
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).
  
  
  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.
authors.affiliation: Department of Urology, University Hospitals, KU Leuven, Belgium.
authors.forename: Manuela
authors.initials: M
authors.lastname: Tutolo
authors.affiliation: Division of Urology, Città della Salute e della Scienza, Molinette Hospital Hospital, University of Studies of Turin, Turin, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Ammirati
authors.affiliation: Department of Urological Research Institute, IRCCS Ospedale San Raffaele, Division of Oncology/Unit of Urology, Milan, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Castagna
authors.affiliation: Department of Urology, St. Lucas Hospital, Gent, Belgium.
authors.forename: Katrien
authors.initials: K
authors.lastname: Klockaerts
authors.affiliation: Department of Urology, Imelda Hospital, Bonheiden, Belgium.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Plancke
authors.affiliation: Urology, St. Blasius Hospital, Dendermonde, Belgium.
authors.forename: Dieter
authors.initials: D
authors.lastname: Ost
authors.affiliation: Department of Urology, University Hospitals, KU Leuven, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Van der Aa
authors.affiliation: Department of Urology, University Hospitals, KU Leuven, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: De Ridder
mesh_terms: D000283:Administration, Intravesical; D000293:Adolescent; D000328:Adult; D000368:Aged; D002809:Chondroitin Sulfates / Q000008:administration & dosage*; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004121:Dimethyl Sulfoxide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014554:Urination; D064804:Urological Agents / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D064804:Urological Agents; D002809:Chondroitin Sulfates; D004121:Dimethyl Sulfoxide
keywords: Chondroitin Sulfates; Cystitis, Interstitial; Dimethyl Sulfoxide