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

Sponsor

Hospital Universitario de Valme (Other)

Overall Status

Completed

CT.gov ID

NCT03686956

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders Obstetric Trauma Physical Disorder Physical Activity	Other: Physiotherapy treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group The therapy lasted two months, at a rate of two sessions per week, with a duration of 45 minutes per session. The program consisted of pelvic floor exercises assisted by manometric biofeedback, which were performed in supine position for 20 minutes. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position. Together with the treatment at the clinic, patients were asked to perform a series of exercises at home, consisting in: 8-12 sustained contractions of 6 seconds, with a subsequent rest period of double the work-time, followed by 3-5 fast contractions of 2 seconds with maximum intensity, resting double the work-time. Domiciliary exercises were performed in supine, siting and standing position.	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.
No Intervention: Control group The control group received an information brochure with recommendations, including the same program of pelvic floor exercises taught to the patients in the experimental group, but without carrying out any kind of supervision by the physiotherapist.

Arm

Intervention/Treatment

Experimental: Experimental group

The therapy lasted two months, at a rate of two sessions per week, with a duration of 45 minutes per session. The program consisted of pelvic floor exercises assisted by manometric biofeedback, which were performed in supine position for 20 minutes. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position. Together with the treatment at the clinic, patients were asked to perform a series of exercises at home, consisting in: 8-12 sustained contractions of 6 seconds, with a subsequent rest period of double the work-time, followed by 3-5 fast contractions of 2 seconds with maximum intensity, resting double the work-time. Domiciliary exercises were performed in supine, siting and standing position.

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.

No Intervention: Control group

The control group received an information brochure with recommendations, including the same program of pelvic floor exercises taught to the patients in the experimental group, but without carrying out any kind of supervision by the physiotherapist.

Outcome Measures

Primary Outcome Measures

To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg) [6 months after randomisation]
To evaluate the changes in pressure in the contractility evaluated by manometry (mm Hg), of the medical floor produced by the treatment of postpartum physiotherapy of the pelvic floor
Changes in muscle thickness (millimeters) of the levator ani muscle [6 months after randomisation]
Changes in muscle thickness (millimeters) of the levator ani muscle, measured with transperineal ultrasound 3-4D

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Vaginal delivery
Cephalic presentation
Primiparity
At term gestation (37-42 weeks)
No prior pelvic floor corrective surgery
Written informed consent

Exclusion Criteria:

Pregnancies with severe maternal or fetal pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Nuestra Señora de Valme	Sevilla		Spain	41014

Sponsors and Collaborators

Hospital Universitario de Valme

Investigators

Principal Investigator: José Antonio García Mejido, Hospital Universitario de Valme

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

José Antonio García Mejido, Dr., Hospital Universitario de Valme

ClinicalTrials.gov Identifier:

NCT03686956

Other Study ID Numbers:

Rehabilitation of the avulsion

First Posted:

Sep 27, 2018

Last Update Posted:

Aug 17, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Floor Disorders

Disease

Study Results

No Results Posted as of Aug 17, 2020