Ishiko 2001 S.
Methods | Randomised controlled trial Duration of study 2 years Monthly uterine ultrasound examination and 6‐monthly endometrial PAP smears Setting: Japan |
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Participants | 66 post‐menopausal women with stress urinary incontinence, age 54 to 75 years, groups comparable at baseline Dropouts: a further 6 by choice, 1 for adverse drug reaction hepatopathy): A, 4; B, 3 Inclusion criteria: stress urinary incontinence alone (based on questionnaires) Exclusion criteria: urgency or mixed urinary incontinence 10% of women had a previous hysterectomy |
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Interventions | A (32): PFMT + oestriol tablet (1 mg/day) B (34): PFMT alone PFMT was taught by a gynaecology specialist, supplemented by videotape. The aim was 15 minutes of exercise a day |
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Outcomes | Persisting incontinence: A: 7/32; B, 11/34 (Mild UI: A, 0/12; B, 2/11: Moderate UI: A, 3/14; B, 5/18: Severe UI: A, 4/6; B, 4/5) Adverse effects: A: 1/36; B, 0/37 No report of effect on uterus |
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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 | Randomly assigned |
Blinding (performance bias and detection bias) All outcomes | High risk | |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 out of 36 withdrew from exercise and oestrogen group 3 out of 37 from exercise only group |