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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05617092). StuddyBuddy aggregates publicly available trial information.