| Methods |
Method of randomisation: not stated
Double‐blind, placebo‐controlled. Number of participants randomised: n = 88
Number of participants analysed: n = 88
Number of withdrawals: 4 in treatment group and 7 in placebo group (discomfort experienced: 2 in treatment and 2 in placebo group, localised adverse reactions (burning and itching) 2 in treatment group and 1 in placebo group; and 4 in the control group did not benefit from therapy
Power calculation and ITT analysis performed
Source of funding: not stated |
| Participants |
Inclusion criteria: participants presented with symptoms and signs of urinary stress incontinence, vaginal atrophy, and histories of recurrent urinary tract infections. None had received oestrogen before the study
Age: 54‐62 years
Source of participants: not stated
Exclusion criteria: women with anatomical lesions of the urogenital tract, such as uterovaginal prolapse, cystocele, and rectocele of grade II or III, presence of severe systemic disorders, thromboembolic diseases, bilary lithiasis, previous breast or uterine cancer, abnormal uterine bleeding, and body mass index of 25 kg/m2 or higher
Location: Sardinia |
| Interventions |
Treatment: intravaginal oestradiol ovules (1 mg) once daily for 2 weeks and then 2 ovules once weekly for 6 months
Control: placebo vaginal ovules same regimen
Duration: 6 months |
| Outcomes |
Vaginal dryness, dyspareunia, vaginal pH, KPI of vaginal epithelium |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias) |
Low risk |
Double‐blinded, placebo‐controlled trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Some outcomes were self‐assessed but unclear whether other outcome assessors were blinded e.g. the pathologists |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data analysed on the basis of ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Unclear risk |
Insufficient information to make a conclusive judgement |
