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 |
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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 |