title: Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study.
abstract: OBJECTIVE
  Studies of antimuscarinics for overactive bladder (OAB) typically use objective and subjective measures to assess efficacy, as each provides unique information about patient outcome. We evaluated the relationships between changes in diary-documented OAB symptoms and other patient-reported outcome (PRO) measures.
  
  
  METHODS
  In VIBRANT, OAB patients received solifenacin (5/10 mg) or placebo for 12 weeks. During the study, patients completed 3-day bladder diaries and other generic and disease-specific PRO measures. Data from both treatment groups were combined (n=738). Categorical changes in diary variables were compared with changes in PRO measures. Partial correlations controlling for treatment and Spearman correlations were also calculated.
  
  
  RESULTS
  Categorical improvements in diary variables were significantly associated with greater improvements in PRO measures. Pair-wise comparisons showed that patients with major symptomatic improvements had significantly greater improvements on PROs vs. those with some or no improvement. Odds ratios ranged from 1.52 to 4.09 (p≤0.002). Linear relationships between changes in PRO measures and diary variables were low to moderate but statistically significant (p<0.001). Partial correlations were highest for diary variables and OAB-Questionnaire Symptom Bother. Spearman correlations ranged from 0.170 to 0.450 (p<0.001).
  
  
  CONCLUSIONS
  In patients with OAB, changes in objectively measured symptoms of urgency, incontinence and frequency showed low-to-moderate correlations to changes in PRO measures. While providing evidence for similar change patterns in symptoms and patient perceptions, correlations were not high, lending support to the concept that in OAB clinical trials, both bladder diaries and PRO measures are important independent measures of efficacy.
authors.affiliation: Neuropsychiatric Research Institute, 120 Eighth Street South, P.O. Box 1415, Fargo, ND 58107, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Crosby
authors.forename: S D
authors.initials: SD
authors.lastname: Mathias
authors.forename: T S
authors.initials: TS
authors.lastname: Marshall
mesh_terms: D000704:Analysis of Variance; D005260:Female; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy; D008297:Male; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011788:Quality of Life; D011812:Quinuclidines / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate