| Methods |
RCT (double‐blind crossover in 5th and 6th weeks of the study); duration of study: 8/52, F/U at 8/52 |
| Participants |
16 post‐menopausal women with urodynamically proven GSI |
| Interventions |
All women (n=16): oestradiol valerate 2mg daily for 3/52, then 1mg for 1/52
group A (n=13): oestradiol 1mg + norephedrine 200mg daily for 2/52 after first 4/52
group B (n=13): oestradiol 1mg + placebo daily for 2/52 after first 4/52
after 2 weeks, groups 1 and 2 crossed over to the opposite arm |
| Outcomes |
Residual urine, MSU, urodynamics, clinical stress test, periurethral vaginal biopsies, subjective symptoms |
| Notes |
No useable data; adverse events: "few and acceptable", very small changes in BP, no uterine bleeding
Losses to follow up: group 2: 2, group 3: 1 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
no description |
| Allocation concealment (selection bias) |
Unclear risk |
no description |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
no description |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
no description |
