| Methods |
Double‐blind RCT, placebo controlled
Power calculation
Duration of study: 6/12
F/U at 1/12, 3/12 and 6/12 |
| Participants |
40 post‐menopausal women
Inclusion criteria: 'urge syndrome', not menstruated for > 12 months or if hysterectomised if oestradiol levels < 150 pmol/L
Exclusion criteria: on medication for 'urge syndrome', diabetes mellitus or insipidus, diuretics, HRT within last 3 months or hormone implant or intramuscular hormone injection within previous year, endometrial thickness > 4 mm or abnormal endometrium on histology, UTI or haematuria, pelvic mass, urogenital prolapse, other contra‐indication to oestrogen therapy
losses to follow up: A: 2, B: 1
Baseline characteristics: BMI A 26.5 (4.3) B 29.0 (6.72); previous hysterectomy A 6 (30%) B 6 (30%); detrusor instability A 7 (35%) B 15 (75%); age at menopause A 46.55, B 47.75 (6.34) years |
| Interventions |
Group A (n=20): 17 beta oestradiol 25mg implant subcutaneously
Group B (n=20): placebo implant subcutaneously |
| Outcomes |
Outcomes measured by frequency/volume chart, King's Healthcare Quality of Life Questionnaire, urinary symptom questionnaire, visual analogue scale of symptom severity, uroflowmetry, video cystourethrography, serum oestradiol levels, endometrial thickness
definition of cure: complete absence of a symptom that had been present at the beginning of the study
Urgency urinary incontinence not cured: A: 8/15, B: 10/14
Stress incontinence not cured: A: 7/10, B: 5/7
Incontinent episodes in 24 hours (n, mean, SD): A: 16, 2 (5), B: 19, 1 (2)
Number of micturitions in 24 hours (n, mean, SD): A: 16, 9 (3), B: 19, 9 (3)
Adverse effects: A: 5 hysterectomy, 9 irregular vaginal bleeding, 1 angina (was felt not related to study medication), 4 breast tenderness, 8 UTIs
B: 1 breast tenderness, 11 UTIs |
| Notes |
|
| 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 |
Low risk |
Double blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
40 women randomised |
