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

Table 2 Study Design Schedule

	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

* After randomisation costs assessment will be made for both groups at 2 and 4 months in order to account for changes
occurring during progression of (PFMT) treatment.
# Compliance is measured only for the PFMT group in order to assure proper training, complications are only related to surgery.

ISSN: 1472-6874