| Methods |
Randomisation by central office using numbers sequentially, no blinding, parallel design, multicentre (27)
Number of women randomised: n = 254
Number of women analysed: n = 251 (134 ring, 117 pessary)
Number of withdrawals: n = 8 (5 in ring group and 3 in pessary group due to adverse events)
Power calculation for sample size performed and analysis by ITT
Source of funding: Pharmacia and Upjohn |
| Participants |
Inclusion criteria: women who report with one bothersome lower tract symptom appearing at least 2 years after spontaneous or surgical postmenopause
Age: 66 (mean)
Source of participants: 26 clinics of practicing gynaecologists and one outpatient department
Exclusion criteria: known or suspected oestrogen dependant neoplasia ovarian or mammary, ovarian or corpus uteri malignancies, vaginal bleeding of unknown origin, clinically significant disease, acute or intermittent porphyria, uterovaginal prolapse of grade II or III, sex or hormone treatment within last 6 months, previous participation in clinical trials within 3 months prior to inclusion, signs of vaginal irritation other than atrophy‐derived or signs of vaginal ulceration
Location: Denmark |
| Interventions |
Treatment: oestradiol releasing vaginal ring (Estring) with constant release of 7.5 mg oestradiol per 24 hours for 3‐month period
Control: oestriol vaginal pessaries (Ovestin) 0.5 mg daily for 3 weeks, followed by 1 pessary every second day for the rest of the 24‐week period |
| Outcomes |
Urgency, frequency, urge incontinence, stress incontinence; nocturia, dysuria, vaginal dryness, dyspareunia, adverse events, assessment of administration |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomisation by central office using numbers sequentially no further details were reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias) |
High risk |
Open label (no blinding) |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear whether other outcome assessors e.g. the pathologists were blinded or not |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were analysed on the basis of ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Low risk |
Treatment groups were balanced at baseline |
