NCT05282160

The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.

Completed NA Last updated 16 March 2022

What this trial tests

NA trial testing Epino in Dyspareunia in 70 participants. Completed in 15 December 2020.

Timeline

15 January 2018

Primary endpoint
15 December 2020

15 December 2020

Quick facts

Lead sponsor	Universidade Estadual de Londrina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	single
Primary purpose	prevention
Enrollment	70
Start date	15 January 2018
Primary completion	15 December 2020
Estimated completion	15 December 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Epino

Conditions studied

• Dyspareunia — all drugs for Dyspareunia →
• Urinary Incontinence — all drugs for Urinary Incontinence →
• Perineal Tear — all drugs for Perineal Tear →
• Perineal Injury — all drugs for Perineal Injury →

Sponsor

Universidade Estadual de Londrina — full company profile →

Who can join

Adults 18 to 35, female only, with Dyspareunia or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Perineal injury is the most common maternal obstetric complication associated with vaginal delivery (1). It is estimated that perineal lacerations of first and second degree occur in 38% of spontaneous vaginal deliveries in primiparous and in 36% in multiparous women (2). The perineal traumas are associated with significant maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological damage (3,4). Episiotomy is a surgical procedure used in obstetrics to increase vaginal opening with an incision in the perineum at end of the second stage of vaginal delivery. However, this procedure is commonly used improperly as routine in the delivery attendance in many health services. For a successful vaginal delivery, the vaginal opening should slowly dilate in order to allow stretching because when the baby descends rapidly, the tissues can tear (11). The degree of muscle stretching or distension in the vaginal delivery may lead to pelvic floor muscle trauma (12). Urinary incontinence is the involuntary loss of urine, with impacts on women in terms of their quality of life, and is considered a social and hygiene problem (16). The muscle strength of the pelvic floor is important for the prevention, diagnosis and treatment of pelvic floor dysfunction. EPI-NO is a device that was invented by a German obstetrician in order to prepare and train the pelvic floor for normal delivery. The purpose of this study is to verify the effect of 10 sessions of pelvic floor elongation with Epi-No in the prevention of urinary incontinence and dyspareunia 6 months after delivery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.