title: Outcomes of patients who declined randomization to MiniMo trial.
abstract: OBJECTIVE
  To evaluate lower urinary tract outcomes of eligible women who declined randomization to MiniArc(®) versus Monarc™ (MiniMo) RCT. To explore reasons why eligible women declined participation.
  
  
  METHODS
  The medical records of 44 women who declined randomization to MiniMo were reviewed. Women had a phone questionnaire at a mean of 2.4 years after surgery (range 1.3-3.9) and asked to document their symptoms at 6 and 12 months after operation, if they had not attended previously. Objective cure was defined as a negative cough stress test. Subjective cure was defined as patient reporting no leak on cough, sneeze or exercise. Outcomes of patients who declined were compared with those who participated in the MiniMo RCT. Women were asked to outline their reasons for declining participation in the MiniMo RCT.
  
  
  RESULTS
  Baseline characteristics were similar except for BMI, which was higher in the declined group compared to the randomized group. Subjective cure at 6 months (79% vs. 94%, p=0.01) and 12 months was significantly lower in the declined group (58% vs. 93%, p<0.001). The commonest reason for declining participation in this study was the requirement for additional follow up.
  
  
  CONCLUSIONS
  Results of RCTs may be overstated compared to standard clinical care as seen in this study.
authors.affiliation: Monash Medical Centre Moorabbin, East Bentleigh, Victoria, Australia. Electronic address: Natharnia.young@monashhealth.org.
authors.forename: Natharnia
authors.initials: N
authors.lastname: Young
authors.affiliation: Monash Medical Centre Moorabbin, East Bentleigh, Victoria, Australia; Mercy Hospital for Women, Heidelberg, Victoria, Australia; University of Melbourne, Carlton, Victoria, Australia.
authors.forename: Joseph
authors.initials: J
authors.lastname: Lee
authors.affiliation: Monash Medical Centre Moorabbin, East Bentleigh, Victoria, Australia; Monash University, Clayton, Victoria, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Rosamilia
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003657:Decision Making; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D018579:Patient Selection; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures
keywords: MiniArc; Monarc; Outcome; Stress incontinence; ‘Declined randomization’