| Methods |
RCT, duration of study: 3/12, follow up at 3/12 and 9/12 |
| Participants |
100 women;
Inclusion criteria: urodynamically proven GSI
Exclusion criteria: complicated history of incontinence such as fistula or more than one previous incontinence surgery, major prolapse, absolute contraindication to oestrogen treatment |
| Interventions |
Group A (n=24): conjugated equine oestrogen vaginal cream (Premarin) 1.25 mg at night for 12/52
Group B (n=25): no treatment |
| Outcomes |
Pad test, urethral pressure studies at 3/12, symptom questionnaire at 9/12
Definition of cure: negative pad test after previous positive; improvement: more than 50% reduction in pad weights |
| Notes |
Numbers given as "cured or improved" and "unchanged"; recurrences of symptoms at 9/12 in women who had initially improved: group A: 3, group B: 1, group C: 3 (recurrence of symptoms immediately after discontinuing oestrogen treatment) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"allocated at random" |
| Allocation concealment (selection bias) |
Unclear risk |
no description |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not possible, drug compared to PFMT |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
100 out of 104 evaluated no info on dropouts |
