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Clinical Trials/NCT04955418
NCT04955418
Completed
Not Applicable

Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions

Universidade Estadual de Londrina1 site in 1 country90 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Disorders
Sponsor
Universidade Estadual de Londrina
Enrollment
90
Locations
1
Primary Endpoint
Effect of birth training with Epi-no
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
January 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Effect of birth training with Epi-no

Time Frame: 6 months after delivery

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 Outcomes

  • Incidence of urinary incontinence and dyspareunia(6 months after delivery)
  • Incidence of dyspareunia(6 months after delivery)
  • Pelvic floor muscle strength(6 months after delivery)

Study Sites (1)

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