Physical Activity Clinical Trial
Official title:
Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D
SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results,
conclusions)
Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions,
identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and
functionality of pelvic floor.
Design: Post-authorization, prospective, longitudinal randomized intervention study
Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term
primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal
ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor
and the non-work.
Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by
manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by
transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury
rate, estimate the sonographic changes in the levator ani muscle through rehabilitation.
Analyze the improvement of the symptoms associated with the public organic prolapse and
evaluate the improvement of the quality of life.
Data analysis: To detect a difference of 10% in the reduction of the size of the index
between the study groups (not intervened / intervened) after 6 months of intervention,
standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each
group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per
group.
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