| Methods | 2‐arm (parallel groups) RCT. | |
| Participants | 75 pregnant nulliparous women. Inclusion: aged 15‐35 years without stress UI at 20 weeks' gestation. Exclusion: multiple pregnancy, ≥ 2 caesarean births, oligohydramnios or polyhydramnios, cervical incompetence, maternal‐fetal iso‐immunisation, severe pregnancy‐induced hypertension, chronic degenerative conditions affecting pelvic floor function such as diabetes mellitus and multiple sclerosis. Age, mean (SD), years: PFMT 26 (6); 24 (7). Parity, mean (SD): PFMT 1.4 (0.8); control 1.4 (0.7). Delivery: PFMT 42.1% vaginal, 57.9% caesarean; control 64.7% vaginal, 35.3% caesarean Weight at 35 weeks' gestation, mean (SD), kg: PFMT 66 (7); control 66 (13). Incontinence at recruitment: none (see inclusion criteria). Setting: single‐centre, Mexico. |
|
| Interventions |
PFMT (n = 38): taught by physiotherapist. 8 × 1‐hour visits over 8 weeks, then weekly telephone calls. Also received information about anatomy and physiology of lower urinary tract, and biofeedback from surface electromyography electrodes (either side of anus) at clinic visits. Control (n = 34): requested not to perform PFMT during pregnancy or postpartum. |
|
| Outcomes | Measured at 28 and 35 weeks' gestation, and 6 weeks' postpartum. Primary endpoint: 6 weeks' postpartum. Primary outcome: self‐reported UI. Secondary outcomes: frequency and severity of UI, cough test, PFM activity (electromyography). |
|
| Notes | Losses to follow‐up: 3/75 (total 4%); data not available by group. Funding: not reported. Conflicts of interest: not reported. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants names in sealed envelopes and assigned random numbers to divide them into 2 groups randomly. |
| Allocation concealment (selection bias) | Low risk | The sealed envelopes were held by the secretary who did not have any relationship to the study: she opened them and assigned the women to each group. |
| 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 self‐report outcomes because they were participant reported. Unclear if cough test and electromyography were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4% dropout; unclear if similar between groups; no reasons provided; no mention of imputation for missing data. |
| Selective reporting (reporting bias) | Low risk | Outcome measures described in methods were reported in results. |
| Other bias | Unclear risk | Significant difference between groups with respect to weight gain during pregnancy (greater in the PFMT group) and self‐reported UI at 28 weeks' gestation (more prevalent in the PFMT group). |