Treatment of Scars and Dysfunctions of the Pelvic Floor i... | NCT04098965

Studies
Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

NCT04098965

Sponsor

Universidad de León

Status

Unknown status

Last Update Posted

Sep 23, 2019Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Pelvic Floor Disorders

Interventions

Pysiotherapy techniques
physician treatment

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2017Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Jul 2020Estimated

First Submitted Date

Sep 17, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2019

Last Update Posted Date

Sep 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MARÍA DEL PILAR VIDALES COLINAS, Principal Investigator, Universidad de LeónPrincipal Investigator

Lead Sponsor

Universidad de LeónOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Physical Therapy Techniques	Other: Pysiotherapy techniques
Control	Other	physician treatment	Other: physician treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pysiotherapy techniques	Other	manual therapy techniques, postural re-education and muscle strengthening	Experimental

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
M. Pilar Master	Contact	+34616965978		pilarvidacoli@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sierrallana	Recruiting	Torrelavega	Cantabria	39300	Spain

Condition Browse Module

MeSH Terms

ID	Term
D059952	Pelvic Floor Disorders

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D011248	Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided