title: Randomized controlled trial of oxybutynin extended release versus placebo for urinary symptoms during intravesical Bacillus Calmette-Guérin treatment.
abstract: OBJECTIVE
  Intravesical bacillus Calmette-Guérin is used to decrease recurrence rates of nonmuscle invasive urothelial carcinoma. Irritative urinary symptoms are a common side effect of treatment and frequently limit treatment tolerance. While anticholinergic medications may be used for symptom prophylaxis, to our knowledge they have not been evaluated in a randomized controlled trial.
  
  
  METHODS
  A total of 50 bacillus Calmette-Guérin naïve patients were randomized to 10 mg extended release oxybutynin daily or placebo starting the day before 6 weekly bacillus Calmette-Guérin treatments. A questionnaire assessing urinary symptoms (frequency, burning on urination, urgency, bladder pain, hematuria), systemic symptoms (flu-like symptoms, fever, arthralgia) and medication side effects (constipation, blurred vision, dry mouth) was recorded daily throughout the therapeutic course. A linear mixed repeated measures model tested the differences between each point and baseline score.
  
  
  RESULTS
  The treatment group had a greater increase in urinary frequency and burning on urination compared to placebo (p = 0.004 and p = 0.04, respectively). There were no significant differences between groups for other urinary symptoms, which increased in severity after bacillus Calmette-Guérin but concomitantly returned to baseline in both groups. The treatment group experienced increases in fever, flu-like symptoms, dry mouth and constipation compared to placebo (p <0.0001, p = 0.0008, p = 0.045 and p = 0.001, respectively). There were otherwise no significant differences in nonurinary symptoms or medication adverse reactions.
  
  
  CONCLUSIONS
  Oxybutynin increased urinary frequency and burning on urination compared to placebo in patients receiving intravesical bacillus Calmette-Guérin treatment. Our results do not support the routine use of oxybutynin as prophylaxis against urinary symptoms during bacillus Calmette-Guérin therapy.
authors.affiliation: Division of Urologic Surgery, Washington University School of Medicine, Saint Louis, Missouri, USA.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Johnson
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Nepple
authors.forename: Vicky
authors.initials: V
authors.lastname: Peck
authors.forename: Kathryn
authors.initials: K
authors.lastname: Trinkaus
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Klim
authors.forename: Gurdarshan S
authors.initials: GS
authors.lastname: Sandhu
authors.forename: Adam S
authors.initials: AS
authors.lastname: Kibel
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000283:Administration, Intravesical; D000368:Aged; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000627:therapeutic use*; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D011446:Prospective Studies; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D003692:Delayed-Action Preparations; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C005419:oxybutynin