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Effects of Epi-no Device on Pelvic Floor Dysfunctions

NCT04955418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-07-08

No results posted yet for this study

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

Interventions

DEVICE

Epi-No®

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

DIAGNOSTIC_TEST

Evaluation

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

Sponsors & Collaborators

  • Universidade Estadual de Londrina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2020-07-31
Completion
2021-01-01

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955418 on ClinicalTrials.gov