title: Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus Calmette-Guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus Calmette-Guerin?
abstract: OBJECTIVE
  We evaluated safety and efficacy outcomes in a case series of subjects who received open label intravesical bacillus Calmette-Guerin after failing to respond to bacillus Calmette-Guerin or intravesical placebo in a randomized clinical trial.
  
  
  METHODS
  Subjects who met National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency were initially randomized to 6 weekly intravesical instillations of bacillus Calmette-Guerin or placebo and followed for a total of 34 weeks. At 34 weeks subjects who reported that they had not responded to treatment were offered treatment with open label bacillus Calmette-Guerin, using the same course of treatment and followup. Outcomes included a patient reported global response assessment, a 24-hour voiding diary, pain, urgency, validated interstitial cystitis symptom indexes and adverse events.
  
  
  RESULTS
  A total of 156 subjects elected open label bacillus Calmette-Guerin, of whom 18 (12%) withdrew during the open label series. The response rate based on the global response assessment was 18% and it was identical between those initially randomized to placebo (first course of bacillus Calmette-Guerin in the open label series) and those initially randomized to bacillus Calmette-Guerin (second course). Small improvements were observed for most secondary efficacy outcomes. Most participants reported at least 1 adverse event, primarily pain, genitourinary symptoms and gastrointestinal disturbances. However, there was no difference in adverse events between those who received the first course of bacillus Calmette-Guerin in this series compared to those who received 2 courses.
  
  
  CONCLUSIONS
  The low response rate for bacillus Calmette-Guerin in this open label case series further argues against the routine use of bacillus Calmette-Guerin as treatment for interstitial cystitis.
authors.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, 6th Floor, 423 Guardian Dr., Philadelphia, Pennsylvania 19104, USA. propert@mail.med.upenn.edu
authors.forename: Kathleen Joy
authors.initials: KJ
authors.lastname: Propert
authors.forename: Robert
authors.initials: R
authors.lastname: Mayer
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Payne
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Peters
authors.forename: Valerie
authors.initials: V
authors.lastname: Teal
authors.forename: David
authors.initials: D
authors.lastname: Burks
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: Harris E
authors.initials: HE
authors.lastname: Foster
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D001500:BCG Vaccine