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NCT05617092
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
Conditions: Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 78
Sponsor: Vastra Gotaland Region
Summary
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future.
The main questions it aims to answer are if a physiotherapy program in women with a levator injury:Can improve the pelvic floor morphometry (PFM).Can improve urogynecological symptomsThe effect of a physiotherapy program in the sexual functionThe effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms.
Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.
Eligibility Criteria
Inclusion Criteria:simplex vaginal first delivery with a elevator ani injuryaged ≥18 yearsunderstands the Swedish language in speech and writingapproves vaginal examinationExclusion Criteria:diagnosed sphincter injury grade 3-4serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)
Source: ClinicalTrials.gov (NCT05617092). StuddyBuddy aggregates publicly available trial information.