title: Treatment success for overactive bladder with urinary urge incontinence refractory to oral antimuscarinics: a review of published evidence.
abstract: BACKGROUND
  Treatment options for overactive bladder (OAB) with urinary urge incontinence (UUI) refractory to oral antimuscarinics include: botulinum toxin type A (BoNTA), sacral neuromodulation (SNM), and augmentation cystoplasty (AC). A standard treatment success metric that can be used in both clinical and economic evaluations of the above interventions has not emerged. Our objective was to conduct a literature review and synthesis of published measures of treatment success for OAB with UUI interventions and to identify a treatment success outcome.
  
  
  METHODS
  We performed a literature review of primary studies that used a definition of treatment success in the OAB with UUI population receiving BoNTA, SNM, or AC. The recommended success outcome was compared to generic and disease-specific health-related quality-of-life (HRQoL) measures using data from a BoNTA treatment study of neurogenic incontinent patients.
  
  
  RESULTS
  Across all interventions, success outcomes included: complete continence (n = 23, 44%), > or = 50% improvement in incontinence episodes (n = 16, 31%), and subjective improvement (n = 13, 25%). We recommend the OAB with UUI treatment success outcome of > or = 50% improvement in incontinence episodes from baseline. Using data from a neurogenic BoNTA treatment study, the average change in the Incontinence Quality of Life questionnaire was 8.8 (95% CI: -4.7, 22.3) higher for those that succeeded (N = 25) versus those that failed (N = 26). The average change in the SF-6D preference score was 0.07 (95% CI: 0.02, 0.12) higher for those that succeeded versus those that failed.
  
  
  CONCLUSIONS
  A treatment success definition that encompasses the many components of underlying OAB with UUI symptoms is currently not practical as a consequence of difficulties in measuring urgency. The treatment success outcome of > or = 50% improvement in incontinence episodes was associated with a clinically meaningful improvement in disease-specific HRQoL for those with neurogenic OAB with UUI. The recommended success definition is less restrictive than a measure such as complete continence but includes patients who are satisfied with treatment and experience meaningful improvement in symptoms. A standardized measure of treatment success will be useful in clinical and health economic applications.
authors.affiliation: School of Pharmacy, University of Washington, Seattle, USA. Jon.Campbell@ucdenver.edu
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Campbell
authors.forename: Katharine S
authors.initials: KS
authors.lastname: Gries
authors.forename: Jonathan H
authors.initials: JH
authors.lastname: Watanabe
authors.forename: Arliene
authors.initials: A
authors.lastname: Ravelo
authors.forename: Roger R
authors.initials: RR
authors.lastname: Dmochowski
authors.forename: Sean D
authors.initials: SD
authors.lastname: Sullivan
mesh_terms: D000284:Administration, Oral; D000818:Animals; D002986:Clinical Trials as Topic / Q000639:trends; D006801:Humans; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D053202:Urinary Incontinence, Urge / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology
chemical_list: D018727:Muscarinic Antagonists