Effects of Epi-no Device on Pelvic Floor Dysfunctions

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955418
• Other study ID #: 2.219.051
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2021
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspareunia
• Lacerations
• Pelvic Floor Disorders
• Urinary Incontinence

Intervention

Device:
• Epi-No®
evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.

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

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Londrina	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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