Clinical trial NCT04955418: Effects of Epi-no Device on Pelvic Floor Dysfunctions
Official title: Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Urinary Incontinence
Dyspareunia
Lacerations Perineal
Keywords: Epi-no device
vaginal birth
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: case-control study
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Effect of birth training with Epi-no
timeFrame: 6 months after delivery
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: 6 months after delivery
measure: Incidence of urinary incontinence and dyspareunia
timeFrame: 6 months after delivery
measure: Incidence of dyspareunia
timeFrame: 6 months after delivery
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Estadual de Londrina
state: Paraná
Study officials:
References: