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Completed

NCT Number: NCT04955418

Effects of Epi-no Device on Pelvic Floor Dysfunctions

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Evaluation

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Pelvic floor muscle strength

    Time frame: 6 months after delivery

    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.

  2. Incidence of urinary incontinence and dyspareunia

    Time frame: 6 months after delivery

    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.

  3. Incidence of dyspareunia

    Time frame: 6 months after delivery

    Compare the incidence of dyspareunia using FISI test among women undergoing 10 sessions of pre-delivery Epi-No with women not undergoing treatment.

Sponsors and collaborators

Lead sponsor

Universidade Estadual de Londrina

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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