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Effects of Epi-no Device on Pelvic Floor Dysfunctions

Primary Purpose

Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Epi-No®
Evaluation
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring Epi-no device, vaginal birth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • primiparous
  • single fetus

Exclusion Criteria:

  • Patients with complaints of urinary incontinence during or before pregnancy
  • hypertension and gestational diabetes
  • placenta previa
  • twin pregnancy
  • multiparous
  • patients who had undergone perineal or vaginal surgery
  • patients who had urinary tract infection, genital herpes or ongoing candidiasis
  • And any other diagnosis in which pregnancy becomes at risk.

Sites / Locations

  • Universidade Estadual de Londrina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Epi-no Group

Control Group

Arm Description

The study group was evaluated before the intervention (between 30 and 32 weeks) and 6 months after delivery.From the 34th week onwards, they performed 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. The pregnant woman was placed in the supine position and EPI-NO® was inserted into vaginal canal. After the introduction of the deflated tube, it was minimally inflated until the perception in the vaginal canal. The first 5 minutes were for perception of the pelvic floor with 10 contractions and relaxation of the perineum in order to maintain muscle strength. After 15 minutes for stretching the perineum, the device was gradually inflated and always respecting the pregnant woman's tolerance. After a total of 20 minutes, the pregnant woman was asked to relax the pelvic floor in order for the inflated device to gently exit her vaginal cavity. The perimeter was measured using a tape measure in its largest diameter.

The control group was evaluated only once, six month after delivery.

Outcomes

Primary Outcome Measures

Effect of birth training with Epi-no
Comparison the frequency of perineal tears and episiotomy between women who underwent 10 sessions of Epi-No in the pre-delivery period with women who did not undergo treatment.

Secondary Outcome Measures

Pelvic floor muscle strength
Compare pelvic floor sensitivity and strength using perineometer between women who underwent 10 sessions of Epi-No in the pre-delivery period with women who did not undergo treatment.
Incidence of urinary incontinence and dyspareunia
Compare the incidence of urinary incontinence using ICIQ-SF test among women undergoing 10 sessions of pre-delivery Epi-No with women not undergoing treatment.
Incidence of dyspareunia
Compare the incidence of dyspareunia using FISI test among women undergoing 10 sessions of pre-delivery Epi-No with women not undergoing treatment.

Full Information

First Posted
April 27, 2021
Last Updated
July 7, 2021
Sponsor
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT04955418
Brief Title
Effects of Epi-no Device on Pelvic Floor Dysfunctions
Official Title
Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
January 1, 2021 (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
No

5. Study Description

Brief Summary
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. EPI-NO is a device with the objective of preparing and training the pelvic floor for normal childbirth, this training allows smooth and slow movement along the perineal structures in the prenatal period, by causing a rapid traumatic laceration during childbirth. The objective of this study is to verify the effect of 10 pelvic stretching rows with Epi-No in preventing urinary incontinence and dyspareunia 6 months after delivery. The study group will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will be evaluated before the intervention and 6 months after delivery. The control group will be evaluated only once, in the sixth month after delivery. The evaluation will consist of: anamnesis, physical examination (vaginal examination and palpation), perineometry, International Urinary Incontinence Questionnaire (ICIQ-UISF), Visual Analogue Scale for dyspareunia; Questionnaire for assessing dyspareunia Female Sexual Function Index (FSFI). Pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. It is expected at the end of the study to prove the effectiveness of the effect of 10 pelvic lengthening graft with Epi-No in relation to the degrees of laceration and episiotomy and, consequently, reduction of urinary incontinence and dyspareunia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia, Lacerations Perineal
Keywords
Epi-no device, vaginal birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
case-control study
Masking
Investigator
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epi-no Group
Arm Type
Active Comparator
Arm Description
The study group was evaluated before the intervention (between 30 and 32 weeks) and 6 months after delivery.From the 34th week onwards, they performed 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. The pregnant woman was placed in the supine position and EPI-NO® was inserted into vaginal canal. After the introduction of the deflated tube, it was minimally inflated until the perception in the vaginal canal. The first 5 minutes were for perception of the pelvic floor with 10 contractions and relaxation of the perineum in order to maintain muscle strength. After 15 minutes for stretching the perineum, the device was gradually inflated and always respecting the pregnant woman's tolerance. After a total of 20 minutes, the pregnant woman was asked to relax the pelvic floor in order for the inflated device to gently exit her vaginal cavity. The perimeter was measured using a tape measure in its largest diameter.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group was evaluated only once, six month after delivery.
Intervention Type
Device
Intervention Name(s)
Epi-No®
Intervention Description
evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation
Intervention Description
evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.
Primary Outcome Measure Information:
Title
Effect of birth training with Epi-no
Description
Comparison the frequency of perineal tears and episiotomy between women who underwent 10 sessions of Epi-No in the pre-delivery period with women who did not undergo treatment.
Time Frame
6 months after delivery
Secondary Outcome Measure Information:
Title
Pelvic floor muscle strength
Description
Compare pelvic floor sensitivity and strength using perineometer between women who underwent 10 sessions of Epi-No in the pre-delivery period with women who did not undergo treatment.
Time Frame
6 months after delivery
Title
Incidence of urinary incontinence and dyspareunia
Description
Compare the incidence of urinary incontinence using ICIQ-SF test among women undergoing 10 sessions of pre-delivery Epi-No with women not undergoing treatment.
Time Frame
6 months after delivery
Title
Incidence of dyspareunia
Description
Compare the incidence of dyspareunia using FISI test among women undergoing 10 sessions of pre-delivery Epi-No with women not undergoing treatment.
Time Frame
6 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: primiparous single fetus Exclusion Criteria: Patients with complaints of urinary incontinence during or before pregnancy hypertension and gestational diabetes placenta previa twin pregnancy multiparous patients who had undergone perineal or vaginal surgery patients who had urinary tract infection, genital herpes or ongoing candidiasis And any other diagnosis in which pregnancy becomes at risk.
Facility Information:
Facility Name
Universidade Estadual de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86038-350
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effects of Epi-no Device on Pelvic Floor Dysfunctions

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