Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

Pelvic Floor Disorders Clinical Trial

— NoRFor  

Official title:

Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098965
• Other study ID #: 321311: FISIOTERAPIA
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: July 2020

Study information

• Verified date: September 2019
• Source: Universidad de León
• Contact: M. Pilar Master
• Phone: +34616965978
• Email: pilarvidacoli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2020
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• Pysiotherapy techniques
manual therapy techniques, postural re-education and muscle strengthening
• physician treatment
hygienic-dietary recommendations, Kegel exercises and pain relievers

Locations

Country	Name	City	State
Spain	Hospital Sierrallana	Torrelavega	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de León

Country where clinical trial is conducted

Spain, 

Outcome

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