Meyer 2001.
Study characteristics | ||
Methods | Design: 2‐arm (parallel groups) RCT. | |
Participants |
Number of participants: 107 pregnant nulliparous women (unclear if this was number recruited or number analysed). Setting: multiple clinics in single centre, Switzerland. Age: mean (SD), years: 29 (4). Not reported by group. Parity: all nulliparous. Delivery: PFMT 30% instrumental; control 16% instrumental. BMI: mean (SD): not reported. Incontinence at recruitment: PFMT 28%; control 32%. Inclusion: pregnant nulliparous women at 12‐39 weeks' gestation at enrolment. Exclusion: pregnancy complications (twin gestation, diabetes, preterm labour, haemorrhage from low‐lying placenta), women beginning labour, history of UTIs. |
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Interventions |
PFMT (n = 51): as part of a PFM rehabilitation programme, taught by a physiotherapist over 6 weeks (12 sessions). Begun at 2 months and ended before 10 months' postpartum. No details of PFMT programme given, but PFMT in clinic was followed by 20 min of biofeedback and 15 min of electrical stimulation. Control (n = 56): no postpartum PFM rehabilitation programme. Received PFMT education at 10 months' postpartum. |
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Outcomes | Measured at 10 months' postpartum. Primary endpoint: 10 months' postpartum. Primary outcome: not reported. Outcome measures: self‐reported UI or FI, sexual response, vaginal digital PFM palpation (graded 0‐5), ultrasonography (bladder volume, bladder neck position at rest, on Valsalva, and with voluntary PFM contraction, supine and standing), urodynamics (functional urethral length, maximal urethral closure pressure at stress (cm of water), area of continence at stress, mean value of pressure transmission ratio in central third of functional urethral length), vaginal and anal squeeze pressure. |
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Notes | No losses to follow‐up. Funding: Swiss National Fund for Scientific Research. Conflicts of interest: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Assigned" in full publication; "randomly assigned" in abstract. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded reporting of UI and FI self‐report outcomes because they were participant‐reported. Not reported if other measures were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data available for all 107 participants randomised. |
Selective reporting (reporting bias) | Low risk | Outcome measures described in methods were reported in results. |
Other bias | Low risk | No other sources of bias noted. |