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

NCT05282160 | Completed DMC

• 1 other identifier: ULondrina1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspareunia; Urinary Incontinence; Perineal Tear; Perineal Injury; Episiotomy Wound; Episiotomy; Complications

Keywords

Pelvic floor; Epino; Birth; Sexual Function; Continence; Perineum

Outcome Measures

Primary Outcomes (2)

• Urinary Incontinence questionnaire

  score of validated questionnaire

  6 months after delivery

• Dyspareunia questionnaire

  score of validated questionnaire

  6 months after delivery

Secondary Outcomes (2)

• Pelvic floor strength

  6 months after delivery

• Quality of life score

  6 months after delivery

Study Arms (2)

Control Group

NO INTERVENTION

The control group (G1) will be composed of puerperal women over 18 years of age attended by Lucila Balalai Municipal Maternity in Londrina. Recruitment will be done through a chart review, which will include single-fetus primiparous that delivered on full term without intercurrence (between 37 and 42 weeks).

Epino Group

EXPERIMENTAL

The study group (G2) will be composed of women over 18 years of age, primigravidae, between 30 and 32 weeks of gestation attended by the Basic Health Units of the central region of Londrina. Only those who agree to participate in the study and sign the free and informed consent form will be included.

Device: Epino

Interventions

Epino DEVICE

The pregnant women will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device (pressure gauge connected to an inflatable soda that simulates the baby's head the vaginal canal). After the introduction of the deflated probe (only the first half of the device), it is minimally inflated until the perception in the vaginal canal. The first 5 minutes will be for perception of the pelvic floor with contraction and relaxation with the purpose of toning and maintaining muscular strength, followed by 15 minutes of perineal elongation respecting the tolerance of the pregnant woman. After 20 minutes in total, the pregnant woman relaxes so that the inflated device leaves gently of her vaginal cavity and the physiotherapist helps at that moment. After the device is removed, note the circumference reached on the day.

Also known as: perineal preparation

Epino Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women over 18 years of age, attended by the Basic Health Units of the central region of Londrina.

You may not qualify if:

• patients with complaint of urinary incontinence or dyspareunia prior to pregnancy, not controled hypertension (SAH) and gestational diabetes, placenta previa, twin pregnancy, who have undergone perineal or vaginal surgeries, who have a urinary tract infection, genital herpes, ongoing candidiasis and any other diagnosis in which the normal delivery becomes a risk.

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (1)

Universidade Estadual de Londrina

Londrina, Paraná, 86057-970, Brazil

Location

MeSH Terms

Conditions

Dyspareunia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SILVIO HM ALMEIDA, DOCTOR

  State University of Londrina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: January 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 16, 2022

Record last verified: 2020-11

Locations

BR (1)