Pelvic Organ Prolapse
Conditions
Keywords
Pelvic organ prolapse; Pelvic floor muscle training; Physiotherapy; Pelvic floor rehabilitation; Conservative treatment; Women
Brief summary
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.
Interventions
OTHERPhysical therapy + educational strategy
See arm/group descriptions
BEHAVIORALEducational strategy
See arm/group descriptions
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two groups: Experimental group and Control group
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Women with stage I or II pelvic organ prolapse (POP), as determined using the Pelvic Organ Prolapse Quantification (POP-Q) system.
Exclusion criteria
* Stage III or IV POP according to the POP-Q system. * Previous conservative treatment or surgery for POP. Neurological, gynecological, or urological conditions that could interfere with the intervention or outcome assessment. * Urinary tract infection or recurrent hematuria. * Current pregnancy or vaginal delivery within the previous 6 months. * Cognitive or language limitations that could prevent participants from understanding the study procedures, providing informed consent, completing the study questionnaires, or adequately participating in the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pelvic floor symptom distress assessed with the Spanish version of the Pelvic Floor Distress Inventory-20 (PFDI-20) | 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention. | 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. |
| 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) | 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pelvic floor muscle strength assessed by perineal manometry | 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention. | 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. |
| Change in pelvic floor muscle strength assessed by vaginal palpation using the Modified Oxford Scale | 5 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, and 12 months after the intervention. | 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. |
| Change in pelvic organ prolapse stage assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system | Baseline, immediately post-intervention, 6 months, and 12 months post-intervention. | 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. |
Countries
Spain
Outcome results
None listed