| Methods |
RCT: placebo controlled, sealed opaque envelopes
Duration of study: 6 months
Follow up: none after end of treatment |
| Participants |
88 post‐menopausal women
Groups comparable at baseline on age, menopause duration, duration of UI, bacteriuria
Inclusion: urodynamic stress incontinence (moderate to severe), urogenital atrophy, recurrent UTI
Exclusion: detrusor overactivity, abnormal maximal cystometric capacity, prolapse Grade II or III; systemic disorders, systemic disease, thromboembolic disease, biliary lithiasis, breast or uterine cancer, abnormal uterine bleeding, BMI>25 |
| Interventions |
Group A (44): intravaginal oestriol ovules, 1 mg daily for 2 weeks, 2 mg weekly for 6 months
Group B (44): matching placebo
Dropout: A: 4/44, B: 3/44 (discomfort, local adverse effects), + B: 4/44 (no benefit) |
| Outcomes |
Incontinent at 6 months: group A: 37/44, group B; 44/44
Not improved at 6 months:group A: 14/44, group B: 37/44
Adverse effects: group A: 4/44,group B: 3/44 (caused dropout)
Significant bacteriuria, group A: 6/44, group B: 20/44 |
| Notes |
Participants and outcome assessors blinded to treatment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
no description |
| Allocation concealment (selection bias) |
Low risk |
"sequenced, sealed, opaque envelopes" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double blind "participants and investigators were blinded to the drug being dispensed and to the assigned treatment group" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No dropouts |
