Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

NCT04098965 | Unknown

• 1 other identifier: 321311: FISIOTERAPIA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Experimental

EXPERIMENTAL

Physical Therapy Techniques

Other: Pysiotherapy techniques

Control

OTHER

physician treatment

Other: physician treatment

Interventions

Pysiotherapy techniques OTHER

manual therapy techniques, postural re-education and muscle strengthening

Experimental

physician treatment OTHER

hygienic-dietary recommendations, Kegel exercises and pain relievers

Control

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de León: lead

Study Sites (1)

Hospital Sierrallana

Torrelavega, Cantabria, 39300, Spain

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

M. Pilar Master

CONTACT

+34616965978; pilarvidacoli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: July 20, 2017
• Primary Completion: July 20, 2018
• Study Completion: July 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

ES (1)