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The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.

NCT05617092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-04-27

No results posted yet for this study

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:

1. Can improve the pelvic floor morphometry (PFM).
2. Can improve urogynecological symptoms
3. The effect of a physiotherapy program in the sexual function
4. The 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.

Conditions

  • Pelvic Floor Disorders
  • Pelvic Floor; Perineal Rupture, Obstetric
  • Physiotherapy

Interventions

OTHER

Physiotherapy treatment

physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Rocio Montejo, PhD · Vastra Gotaland Region

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617092 on ClinicalTrials.gov