NCT03686956

Repair by Rehabilitation of Pelvic Floor Lesions After Vaginal Delivery Identified by Transperineal Ultrasound 3/4 D

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Hospital Universitario de Valme · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pelvic Floor Disorders
• Obstetric Trauma
• Physical Disorder
• Physical Activity

Interventions

Type	Name	Description
OTHER	Physiotherapy treatment	Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2018-09-27
• Last updated: 2020-08-17

Locations

1 site across 1 country: Spain