Effects of Epi-no Device on Pelvic Floor Dysfunctions

NCT04955418 | Completed

• 1 other identifier: 2.219.051
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Dyspareunia; Lacerations Perineal

Keywords

Epi-no device; vaginal birth

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after delivery

Secondary Outcomes (3)

• Pelvic floor muscle strength

  6 months after delivery

• Incidence of urinary incontinence and dyspareunia

  6 months after delivery

• Incidence of dyspareunia

  6 months after delivery

Study Arms (2)

Epi-no Group

ACTIVE COMPARATOR

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.

Device: Epi-No®; Diagnostic Test: Evaluation

Control Group

PLACEBO COMPARATOR

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

Diagnostic Test: Evaluation

Interventions

Epi-No® DEVICE

evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.

Epi-no Group

Evaluation DIAGNOSTIC_TEST

evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.

Control Group; Epi-no Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• primiparous
• single fetus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Universidade Estadual de Londrina

Londrina, Paraná, 86038-350, Brazil

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Dyspareunia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case-control study

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: July 8, 2021
• Study Start: October 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: January 1, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

BR (1)