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. 2012 Oct 17;2012(10):CD001405. doi: 10.1002/14651858.CD001405.pub3

Lose 2000 L.

Methods Open, randomised, multicentre, parallel‐group controlled trial with an active control, 26 gynaecologists clinics + 1 outpatient clinic at Danish county hospital; duration of study: 24/52
Participants 251 post‐menopausal women 
 Inclusion criteria: at least 1 bothersome lower urinary tract symptom appearing at least 2 years after spontaneous or surgical postmenopause
Exclusion criteria: known or suspected oestrogen‐dependent neoplasia, mammary, ovarian, uterine malignancies, vaginal bleeding of unknown origin, clinically significant liver disease, acute or intermittent porphyria, uterovaginal prolapse grade II or III, sex hormone treatment within last 6/12, previous participation in clinical trials within 3/12 prior to inclusion, signs of vaginal irritation other than atrophy derived, signs of vaginal ulceration
Interventions Group A (n=134): oestradiol releasing vaginal ring, which constantly releases 7.5 mg oestradiol/24 hours, ring staying in situ for 12/52, then changed, in total treatment for 24/52 
 Group B (n=117): oestriol vaginal pessaries 0.5 mg every 2nd day for 24/52
Outcomes Questionnaire with symptom assessment using visual analogue scale, gynaecological examination including atrophy and pH assessment, assessment of form of administration using 5‐point scale questionnaire, primary outcomes: 
 subjective assessment of urgency, frequency, nocturia, dysuria, stress and urgency urinary incontinence, secondary outcomes: 
 vaginal dryness, dyspareunia 
 Definition of cure: 'symptom‐free': change from 'a minor problem / a problem / a major problem' to 'no problem'; improvement: change from 'a problem' to 'a minor problem' or from 'a major problem' to 'a problem / a minor problem', failure: 'no change': no change from 'a minor problem / a problem / a major problem', 'worse': change from 'no problem' to 'a minor problem / a problem / a major problem' or from 'a minor problem' to 'a problem / a major problem' or from 'a problem' to 'a major problem'
Notes Losses to follow up: group A: 5, group B: 3 
 Adverse outcomes: 49 women experienced at least one adverse event: 34 adverse events in group A , 42 adverse events in group B 
 Primary objective was to show equivalence between the two treatments
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk no description
Allocation concealment (selection bias) Low risk Central office using numbers sequentially. No number was to be omitted
Blinding (performance bias and detection bias) 
 All outcomes High risk Open
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 254 randomised, three did not receive treatment 251 eligible for intention‐to‐treat analysis