OBJECTIVE: To evaluate the effectiveness of an individualized pelvic floor physiotherapy programme combined with lifestyle education compared with lifestyle education alone in women with stage I or II pelvic organ prolapse (POP). DESIGN: Randomized controlled clinical trial with blinded outcome assessment. A total of 120 women were randomly allocated to an experimental group receiving an individualized pelvic floor physiotherapy programme plus lifestyle education or to a control group receiving lifestyle education alone. Assessments were performed at baseline, immediately after the intervention, and at 3, 6, and 12 months. PRIMARY OUTCOMES: Pelvic floor symptoms and their impact on daily life, assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7). SECONDARY OUTCOMES: Anatomical pelvic organ prolapse stage and pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale and by perineal manometry. DATA ANALYSIS: Treatment effectiveness will be evaluated by comparing changes over time between groups throughout the 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
See arm/group descriptions
See arm/group descriptions
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, Spain
Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20)
The PFDI-20 is a 20-item patient-reported outcome measure assessing symptom distress related to pelvic floor disorders. It comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6). Each subscale is scored from 0 to 100, with higher scores indicating greater symptom distress. The total PFDI-20 score ranges from 0 to 300, with higher scores indicating greater overall pelvic floor symptom distress.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in the impact of pelvic floor symptoms on daily activities assessed with the Spanish version of the Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
The PFIQ-7 is a 21-item patient-reported outcome measure comprising three 7-item subscales: the Urinary Impact Questionnaire-7 (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire-7 (POPIQ-7), and Colorectal-Anal Impact Questionnaire-7 (CRAIQ-7). Each subscale is scored from 0 to 100, with higher scores indicating greater impact of pelvic floor symptoms on daily activities. The total PFIQ-7 score ranges from 0 to 300, with higher scores indicating greater overall impact.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic floor muscle strength assessed by perineal manometry
Pelvic floor muscle strength will be assessed using perineal manometry. Three maximal voluntary pelvic floor muscle contractions will be performed, and the mean value will be used for analysis. Higher values indicate greater pelvic floor muscle strength.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale
Pelvic floor muscle strength will be assessed by vaginal palpation using the Modified Oxford Scale, ranging from 0 (no contraction) to 5 (strong contraction). Higher scores indicate greater pelvic floor muscle strength.
Time frame: 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention.
Change in pelvic organ prolapse stage assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system
Pelvic organ prolapse stage will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. POP will be classified as stage 0, I, II, III, or IV according to the most distal portion of the prolapse relative to the hymen. Lower stages indicate less severe prolapse.
Time frame: Baseline, immediately post-intervention, 6 months, and 12 months post-intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.