Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum (NoRFor)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Other: Pysiotherapy techniques; Other: physician treatment

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cantabria
    • Torrelavega, Cantabria, Spain, 39300
      • Recruiting
      • Hospital Sierrallana
      • Contact: M. Pilar Vidales Colinas; Phone Number: +34 616965978; Email: pilarvidacoli@hotmail.com
      • Principal Investigator: María del Pilar Vidales Colinas
      • Sub-Investigator: Carmen Vega Gudino
      • Sub-Investigator: Jesús Mazaira Salcedo
      • Sub-Investigator: María Angeles Matute
      • Sub-Investigator: Gerardo Ballesteros Olmos
      • Sub-Investigator: Ana Canga Villegas
      • Sub-Investigator: Jesús Seco Calvo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Physical Therapy Techniques	Other: Pysiotherapy techniques; manual therapy techniques, postural re-education and muscle strengthening
OTHER: Control; physician treatment	Other: physician treatment; hygienic-dietary recommendations, Kegel exercises and pain relievers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Universidad de León

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ACTUAL): July 20, 2018
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 321311: FISIOTERAPIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No