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The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.

Primary Purpose

Dyspareunia, Urinary Incontinence, Perineal Tear

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Epino
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyspareunia focused on measuring Pelvic floor, Epino, Birth, Sexual Function, Continence, Perineum

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Primiparous women over 18 years of age, attended by the Basic Health Units of the central region of Londrina.

Exclusion Criteria:

  • patients with complaint of urinary incontinence or dyspareunia prior to pregnancy, not controled hypertension (SAH) and gestational diabetes, placenta previa, twin pregnancy, who have undergone perineal or vaginal surgeries, who have a urinary tract infection, genital herpes, ongoing candidiasis and any other diagnosis in which the normal delivery becomes a risk.

Sites / Locations

  • Universidade Estadual de Londrina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Epino Group

Arm Description

The control group (G1) will be composed of puerperal women over 18 years of age attended by Lucila Balalai Municipal Maternity in Londrina. Recruitment will be done through a chart review, which will include single-fetus primiparous that delivered on full term without intercurrence (between 37 and 42 weeks).

The study group (G2) will be composed of women over 18 years of age, primigravidae, between 30 and 32 weeks of gestation attended by the Basic Health Units of the central region of Londrina. Only those who agree to participate in the study and sign the free and informed consent form will be included.

Outcomes

Primary Outcome Measures

Urinary Incontinence questionnaire
score of validated questionnaire
Dyspareunia questionnaire
score of validated questionnaire

Secondary Outcome Measures

Pelvic floor strength
number measured by intravaginal perineometry
Quality of life score
score of validated questionnaire

Full Information

First Posted
March 7, 2022
Last Updated
March 7, 2022
Sponsor
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT05282160
Brief Title
The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.
Official Title
The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function in Women 6 Months After Delivery.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Estadual de Londrina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery (1). It is estimated that perineal lacerations of first and second degree occur in 38% of spontaneous vaginal deliveries in primiparous and in 36% in multiparous women (2). The perineal traumas are associated with significant maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological damage (3,4). Episiotomy is a surgical procedure used in obstetrics to increase vaginal opening with an incision in the perineum at end of the second stage of vaginal delivery. However, this procedure is commonly used improperly as routine in the delivery attendance in many health services. For a successful vaginal delivery, the vaginal opening should slowly dilate in order to allow stretching because when the baby descends rapidly, the tissues can tear (11). The degree of muscle stretching or distension in the vaginal delivery may lead to pelvic floor muscle trauma (12). Urinary incontinence is the involuntary loss of urine, with impacts on women in terms of their quality of life, and is considered a social and hygiene problem (16). The muscle strength of the pelvic floor is important for the prevention, diagnosis and treatment of pelvic floor dysfunction. EPI-NO is a device that was invented by a German obstetrician in order to prepare and train the pelvic floor for normal delivery. The purpose of this study is to verify the effect of 10 sessions of pelvic floor elongation with Epi-No in the prevention of urinary incontinence and dyspareunia 6 months after delivery.
Detailed Description
The control group (G1) will be composed of women over 18 years of age attended by Lucila Balalai Municipal Maternity in Londrina. Recruitment will be done through a chart review, which will include single-fetus primiparous that delivered on full term without intercurrence (between 37 and 42 weeks). After birth they will receive project information while still hospitalized and are scheduled for evaluation 5 months after delivery if they consent to participate in the project. The study group (G2) will be composed of women over 18 years of age, primigravidae, between 30 and 32 weeks of gestation attended by the Basic Health Units of the central region of Londrina. Only those who agree to participate in the study and sign the free and informed consent form (Appendix 1) will be included. Group one will be evaluated before the intervention (between 30th and 32nd week) and 6 months after delivery. The control group will be evaluated only once in the sixth month after delivery. The evaluators will be blind and the evaluation will be composed by: Anamnesis containing data on pregnancy and delivery (hours of expulsive period, use of instruments and / or maneuvers, degree of laceration, episiotomy, and characterization of possible urinary or sexual complaints); Physical examination: inspection and vaginal palpation in order to verify the capacity of external and internal perineal contraction and tenderness with touch; Visual Analogue Scale for dyspareunia included; Validated sexual dysfunction assessment questionnaire for Portuguese: Female Sexual Function Index (FSFI) . Quality of life questionnaire SF-36. The pregnant women will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device (pressure gauge connected to an inflatable soda that simulates the baby's head the vaginal canal). The evaluations and sessions of Epi-No will be individual and will take place in the research laboratory of the physiotherapy outpatient clinic of the University Hospital of Londrina. The protocol was developed by a group of researchers based on the suggestions of already developed studies and clinical practice. After the introduction of the deflated probe (only the first half of the device), it is minimally inflated until the perception in the vaginal canal. The first 5 minutes will be for perception of the pelvic floor with contraction and relaxation with the purpose of toning and maintaining muscular strength, followed by 15 minutes of perineal elongation respecting the tolerance of the pregnant woman. After 20 minutes in total, the pregnant woman relaxes so that the inflated device leaves gently of her vaginal cavity and the physiotherapist helps at that moment. After the device is removed, note the circumference reached on the day. After the procedure the pregnant woman sits on the ball and performs some contractions of perineum to relieve the eventual sensation of burning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Urinary Incontinence, Perineal Tear, Perineal Injury, Episiotomy Wound, Episiotomy; Complications
Keywords
Pelvic floor, Epino, Birth, Sexual Function, Continence, Perineum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group (G1) will be composed of puerperal women over 18 years of age attended by Lucila Balalai Municipal Maternity in Londrina. Recruitment will be done through a chart review, which will include single-fetus primiparous that delivered on full term without intercurrence (between 37 and 42 weeks).
Arm Title
Epino Group
Arm Type
Experimental
Arm Description
The study group (G2) will be composed of women over 18 years of age, primigravidae, between 30 and 32 weeks of gestation attended by the Basic Health Units of the central region of Londrina. Only those who agree to participate in the study and sign the free and informed consent form will be included.
Intervention Type
Device
Intervention Name(s)
Epino
Other Intervention Name(s)
perineal preparation
Intervention Description
The pregnant women will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device (pressure gauge connected to an inflatable soda that simulates the baby's head the vaginal canal). After the introduction of the deflated probe (only the first half of the device), it is minimally inflated until the perception in the vaginal canal. The first 5 minutes will be for perception of the pelvic floor with contraction and relaxation with the purpose of toning and maintaining muscular strength, followed by 15 minutes of perineal elongation respecting the tolerance of the pregnant woman. After 20 minutes in total, the pregnant woman relaxes so that the inflated device leaves gently of her vaginal cavity and the physiotherapist helps at that moment. After the device is removed, note the circumference reached on the day.
Primary Outcome Measure Information:
Title
Urinary Incontinence questionnaire
Description
score of validated questionnaire
Time Frame
6 months after delivery
Title
Dyspareunia questionnaire
Description
score of validated questionnaire
Time Frame
6 months after delivery
Secondary Outcome Measure Information:
Title
Pelvic floor strength
Description
number measured by intravaginal perineometry
Time Frame
6 months after delivery
Title
Quality of life score
Description
score of validated questionnaire
Time Frame
6 months after delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primiparous women over 18 years of age, attended by the Basic Health Units of the central region of Londrina. Exclusion Criteria: patients with complaint of urinary incontinence or dyspareunia prior to pregnancy, not controled hypertension (SAH) and gestational diabetes, placenta previa, twin pregnancy, who have undergone perineal or vaginal surgeries, who have a urinary tract infection, genital herpes, ongoing candidiasis and any other diagnosis in which the normal delivery becomes a risk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SILVIO HM ALMEIDA, DOCTOR
Organizational Affiliation
STATE UNIVERSITY OF LONDRINA
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Estadual de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86057-970
Country
Brazil

12. IPD Sharing Statement

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The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.

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