Effects of Epi-no Device on Pelvic Floor Dysfunctions
Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia
About this trial
This is an interventional prevention trial for Pelvic Floor Disorders focused on measuring Epi-no device, vaginal birth
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.
Sites / Locations
- Universidade Estadual de Londrina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Epi-no Group
Control Group
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.
The control group was evaluated only once, six month after delivery.