Effects of Epi-no Device on Pelvic Floor Dysfunctions

Universidade Estadual de Londrina

Status

Completed

Conditions

Pelvic Floor Disorders

Dyspareunia

Lacerations Perineal

Urinary Incontinence

Treatments

Diagnostic Test: Evaluation

Device: Epi-No®

Study type

Interventional

Funder types

Other

Identifiers

NCT04955418

2.219.051

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups, including a placebo group

Epi-no Group

Active Comparator group

Description:

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.

Treatment:

Device: Epi-No®

Diagnostic Test: Evaluation

Control Group

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: Evaluation