Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

Not Applicable

• Conditions: Pelvic Floor Disorders

• Registration Number: NCT04098965
• Lead Sponsor: Universidad de León

Brief Summary

Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.

At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Primary Completion: 2018-07-20
• Status Verified: 2019-09
• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-19
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-23
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Patients who have dysfunctions in the pelvic floor after childbirth
• Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
• Patients who do not have any medical alteration that does not indicate the treatment

Exclusion Criteria

• Patients who do not have pelvic floor dysfunctions after childbirth
• Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
• Patients who have any medical changes that counter the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
change in VAS from the start to the end	in the begining, at thirth month, at sixth month and at the finish (one year later)	Pain
Change in SF36 from de start to the end	in the begining, at thirth month, at sixth month and at the finish (one year later)	quality of life sorth form
Change in EPIQ from de start to the end	in the begining, at thirth month, at sixth month and at the finish (one year later)	Epidemiology of Prolapse and Incontinence Questionnaire
Change in OXFORD from the start to the end	in the begining, at thirth month, at sixth month and at the finish (one year later)	muscle strength

Trial Locations

Locations (1)

Hospital Sierrallana; 🇪🇸 Torrelavega, Cantabria, Spain