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Table 2 Study Design Schedule

From: Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence

  Baseline visit Randomisation study entry 2, 4 months* 6 months visit 12 months visit 18 months visit
Patient characteristics X Checking Inclusion & Exclusion Criteria      
Gynaecologic examination X      X  
Assessment of pelvic floor functioning X     X X  
48 hour bladder diary X     X X  
Flow X     X X  
Residual volume X     X X  
Stress test X     X X  
Sandvik index X     X X  
24 hour pad test X      X  
Global Impression of severity X    X X X X
Global Impression of improvement     X X X X
EQ-5D    X   X X X
UDI X     X X X
IIQ X     X X X
Costs assessment*    X X X X X
Compliance with treatment #     X   X  
Complications of surgery#     X    
  1. * After randomisation costs assessment will be made for both groups at 2 and 4 months in order to account for changes
  2. occurring during progression of (PFMT) treatment.
  3. # Compliance is measured only for the PFMT group in order to assure proper training, complications are only related to surgery.