The purpose of the study is to compare the efficacy of different modalities of motor learning of pelvic floor muscle contraction in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
See information included in arm/group descriptions.
See information included in arm/group descriptions.
See information included in arm/group descriptions.
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain
María Torres-Lacomba
Alcalá de Henares, Madrid, Spain
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, Spain
Change in life impact of pelvic floor dysfunction
It will be assessed by the Pelvic Floor Impact Questionnaire-7 (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.
Change in symptoms and quality of life
It will be assessed by the Pelvic Floor Distress Inventory-20 (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 (POP) Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about Urinary Incontinence (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 pelvic floor muscle strength by manual scale
It will be measured by Modified Oxford Scale to rate pelvic floor muscle contraction on a scale of 0-5: 0 = no contraction; 1 = minor muscle; 'flicker'; 2 = weak muscle; contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction.
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
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See information included in arm/group descriptions.
Change in pelvic floor muscle strength by dynamometry
It will be measured by dynamometry (measured in GRAMS).
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in pelvic floor muscle passive tone
It will be measured by dynamometry (measured in GRAMS).
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
It will be measured by Ultrasound
Time frame: 5 assessments to evaluate change from baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.