Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after vaginal delivery.
Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelviperineal physical therapy plus pelvic health education and training in the Knack manoeuvre; Experimental group II: hypopressive exercises plus pelvic health education and training in the Knack manoeuvre; Control group: pelvic health education, training in the Knack manoeuvre, and general recommendations for pelvic floor muscle exercises at home. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6 and12 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: The sample size was calculated a priori using the PFDI-20 as the primary outcome. Based on a clinically meaningful between-group difference of 20 points and an SD of change of 31.2 points, 55 participants per group were required. A total of 165 participants were randomized (55 per group). Data analysis: A descriptive analysis will be performed for all variables. Intervention effects will be assessed using linear mixed-effects models for change from baseline, including group, time, and group-by-time interaction as fixed effects, with adjustment for the centered baseline value of the outcome and a participant-specific random intercept. A two-sided significance level of 0.05 will be used.
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Exclusion Criteria: