Effects of Epi-no Device on Pelvic Floor Dysfunctions

Study Overview
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Brief Summary
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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.

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

Conditions
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Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia, Lacerations Perineal

Intervention / Treatment
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* Device: Epi-No®
* Diagnostic Test: Evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: case-control study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epi-no Group<br>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®<br>* evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.<br>Diagnostic Test: Evaluation<br>* evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.<br>|
| Placebo Comparator: Control Group<br>The control group was evaluated only once, six month after delivery. | Diagnostic Test: Evaluation<br>* evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after delivery | 
| 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. | 6 months after delivery | 
| 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. | 6 months after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epi-no device, vaginal birth