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COMPLETED
NCT03244397
NA

Physical Therapy on Pelvic Organ Prolapse

Sponsor: University of Alcala

View on ClinicalTrials.gov

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.

Official title: Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II

Key Details

Gender

FEMALE

Age Range

25 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2017-08-08

Completion Date

2021-12-28

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

OTHER

Physical therapy + educational strategy

See arm/group descriptions

BEHAVIORAL

Educational strategy

See arm/group descriptions

Locations (2)

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