title: Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial.
abstract: BACKGROUND
  Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients.
  
  
  METHODS
  We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death.
  
  
  RESULTS
  It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence.
  
  
  CONCLUSIONS
  The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered.
  
  
  BACKGROUND
  ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.
authors.affiliation: School of Health, University of Central Lancashire, Victoria Street, Preston PR1 2HE, UK. lhthomas@uclan.ac.uk.
authors.forename: Lois H
authors.initials: LH
authors.lastname: Thomas
authors.forename: Caroline L
authors.initials: CL
authors.lastname: Watkins
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Sutton
authors.forename: Denise
authors.initials: D
authors.lastname: Forshaw
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Leathley
authors.forename: Beverley
authors.initials: B
authors.lastname: French
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Burton
authors.forename: Francine
authors.initials: F
authors.lastname: Cheater
authors.forename: Brenda
authors.initials: B
authors.lastname: Roe
authors.forename: David
authors.initials: D
authors.lastname: Britt
authors.forename: Joanne
authors.initials: J
authors.lastname: Booth
authors.forename: Elaine
authors.initials: E
authors.lastname: McColl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition; D015928:Cognitive Behavioral Therapy; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D016017:Odds Ratio; D018579:Patient Selection; D011788:Quality of Life; D020127:Recovery of Function; D018401:Sample Size; D020521:Stroke / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology*; D014549:Urinary Incontinence / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D014563:Urodynamics; D014852:Wales