title: INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing.
abstract: BACKGROUND
  Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness.
  
  
  METHODS
  This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions.
  
  
  CONCLUSIONS
  The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN71327395 assigned 7th June 2010.
authors: Directorate of Women's Services, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
authors: Megan
authors: M
authors: Murdoch
authors: Elaine
authors: E
authors: McColl
authors: Denise
authors: D
authors: Howel
authors: Mark
authors: M
authors: Deverill
authors: Brian S
authors: BS
authors: Buckley
authors: Malcolm
authors: M
authors: Lucas
authors: Christopher R
authors: CR
authors: Chapple
authors: Douglas G
authors: DG
authors: Tincello
authors: Natalie
authors: N
authors: Armstrong
authors: Cath
authors: C
authors: Brennand
authors: Jing
authors: J
authors: Shen
authors: Luke
authors: L
authors: Vale
authors: Paul
authors: P
authors: Hilton
mesh_terms: D001291:Attitude of Health Personnel; D005240:Feasibility Studies; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D018579:Patient Selection; D010865:Pilot Projects; D011237:Predictive Value of Tests; D036301:Qualitative Research; D019057:Quality-Adjusted Life Years; D012107:Research Design; D016896:Treatment Outcome; D006113:United Kingdom; D014549:Urinary Incontinence / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures