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

Primary Purpose

Pelvic Floor Disorders

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Pysiotherapy techniques

physician treatment

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital SierrallanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Physical Therapy Techniques

physician treatment

Outcomes

Primary Outcome Measures

change in VAS from the start to the end

Pain

Change in SF36 from de start to the end

quality of life sorth form

Change in EPIQ from de start to the end

Epidemiology of Prolapse and Incontinence Questionnaire

Change in OXFORD from the start to the end

muscle strength

Secondary Outcome Measures

Full Information

NCT ID

NCT04098965

First Posted

September 17, 2019

Last Updated

September 19, 2019

Sponsor

Universidad de León

1. Study Identification

Unique Protocol Identification Number

NCT04098965

Brief Title

Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

Acronym

NoRFor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 20, 2017 (Actual)

Primary Completion Date

July 20, 2018 (Actual)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de León

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Floor Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Physical Therapy Techniques

Arm Title

Control

Arm Type

Other

Arm Description

physician treatment

Intervention Type

Other

Intervention Name(s)

Pysiotherapy techniques

Intervention Description

manual therapy techniques, postural re-education and muscle strengthening

Intervention Type

Other

Intervention Name(s)

physician treatment

Intervention Description

hygienic-dietary recommendations, Kegel exercises and pain relievers

Primary Outcome Measure Information:

Title

change in VAS from the start to the end

Description

Pain

Time Frame

in the begining, at thirth month, at sixth month and at the finish (one year later)

Title

Change in SF36 from de start to the end

Description

quality of life sorth form

Time Frame

in the begining, at thirth month, at sixth month and at the finish (one year later)

Title

Change in EPIQ from de start to the end

Description

Epidemiology of Prolapse and Incontinence Questionnaire

Time Frame

in the begining, at thirth month, at sixth month and at the finish (one year later)

Title

Change in OXFORD from the start to the end

Description

muscle strength

Time Frame

in the begining, at thirth month, at sixth month and at the finish (one year later)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

M. Pilar Master

Phone

+34616965978

pilarvidacoli@hotmail.com

Facility Information:

Facility Name

Hospital Sierrallana

City

Torrelavega

State/Province

Cantabria

ZIP/Postal Code

39300

Country

Spain

Individual Site Status

Recruiting

Facility Contact: