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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
165
See information included in arm/group descriptions.
See information included in arm/group descriptions.
See information included in arm/group descriptions.
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, Spain
Change in symptoms and quality of life
It will be assessed by PFDI-20 Spanish version that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in life impact of pelvic floor dysfunction
It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Pelvic floor muscle contraction and strenght
Vaginal palpation will qualify PFM contraction and strength. using the Modified Oxford Score ranging from 0 to 5, according to the muscles contraction and strength.
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Changes in sexual function
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It will be assessed using the Spanish version of the Female Sexual Function Index (FSFI). The FSFI consists of 19 items assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain, with higher scores indicating better sexual function.
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle strength and tone
It will be measured with dynamometry (gr)
Time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.