Liapis 2010 L.

Methods	Prospective randomised study between February 2004 and January 2009. Intention‐to‐treat analysis
Participants	188 randomised, 183 patients completed study Inclusion: Post‐menopausal, stress urinary incontinence Exclusion: Urge or mixed incontinence. Cystocoele > stage II.
Interventions	Group 1 (n=92): Underwent TVT‐O anti‐incontinence surgery followed by vaginal oestradiol treatment Group 2 (n=91): Underwent TVT‐O surgery only Patients in group 1 took 25 micrograms oestradiol vaginally once daily, nocte, for 2 weeks and then twice weekly for 6 months.
Outcomes	Patients asked to complete 3 day bladder diary, uroflow, filling and voiding cystometry and urethral profilometry pre‐operatively and at 2 and 6 months follow up. Primary: Post‐operative symptoms (frequency, urgency, nocturia) Secondary: Maximum flow rate, maximum cystometric capacity, maximum urethral closure pressure, maximum urethral length, detrusor pressure at maximum flow, maximum detrusor pressure and post‐void residual. In general, the oestradiol treated group had a statistically significant better outcome compared to the non‐oestradiol one.
Notes	Subjective cure was considered as the absence of urine leaking with coughing, sneezing, weight lifting as stated by the patient. At the 6 month review, 78 and 75 patients were continent in group 1 and group 2 respectively. One patient in each of the groups did not receive the allocated treatment (either oestradiol or TVT‐O surgery)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomised" ‐ no further explanation
Allocation concealment (selection bias)	Unclear risk	no description
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No mention of blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	188 participants randomised, 5 lost to follow up (2 lost to follow up in group 2, 3 lost to follow up in group 2)