| Methods |
Double‐blind placebo controlled RCT, randomisation into two treatment groups by block randomisation using random numbers Duration of study: 12/52; assessment at 4/52, 8/52, 12/52 |
| Participants |
29 post‐menopausal women
Inclusion criteria: stress urinary incontinence documented by pad‐weighing test, >1year post‐menopausal including iatrogenic menopause, no oestrogen treatment < 2/12 prior to study,patients expected to comply with protocol including treatment on outpatient basis, stable cystometry, no evidence of obstruction
Exclusion criteria: neurological disease and senility, diabetes mellitus, liver dysfunction, previous cancer of breast or uterus, hypertension (diastolic > 100 mmHg), concomitant treatment with drugs affecting the lower urinary tract |
| Interventions |
Group A (n=15): placebo for 4/52 (period 1), then phenylpropanolamine (PPA) 50mg twice daily + placebo for 4/52 (period 2), then PPA 50mg twice daily + oestriol 4mg daily for 4/52 (period 3)
Group B (n=14): placebo for 4/52 (period 1), then oestriol 4mg daily + placebo for 4/52 (period 2), then PPA 50mg twice daily + oestriol 4mg daily for 4/52 (period 3) |
| Outcomes |
Subjective drug preference, 3‐day urinary diary, incontinence, median voiding frequency, mean number of leakage episodes, pad test, vaginal cytology, urine cultures, side effects, heart rate, BP |
| Notes |
Adverse events: 5 in placebo period, 6 in PPA period, 5 in oestriol period, 7 in PPA + oestriol period
Losses to follow up: 1 during PPA period, 1 after period 2 of study (not specified which group) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation into two treatment groups by block randomisation using random numbers |
| Allocation concealment (selection bias) |
Low risk |
Randomisation into two treatment groups by block randomisation using random numbers |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Women were blind to treatment |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
no description |
