The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.
Condition: Dyspareunia; Urinary Incontinence; Perineal Tear; Perineal Injury; Episiotomy Wound; Episiotomy; Complications
MeSH terms: Urinary Incontinence; Dyspareunia
Study type: Interventional

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.
    

Detailed description: 
      The control group (G1) will be composed of 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). After birth they will receive project information while still
      hospitalized and are scheduled for evaluation 5 months after delivery if they consent to
      participate in the project. 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 (Appendix 1) will be included.

      Group one will be evaluated before the intervention (between 30th and 32nd week) and 6 months
      after delivery. The control group will be evaluated only once in the sixth month after
      delivery. The evaluators will be blind and the evaluation will be composed by:

        -  Anamnesis containing data on pregnancy and delivery (hours of expulsive period, use of
           instruments and / or maneuvers, degree of laceration, episiotomy, and characterization
           of possible urinary or sexual complaints);

        -  Physical examination: inspection and vaginal palpation in order to verify the capacity
           of external and internal perineal contraction and tenderness with touch;

        -  Visual Analogue Scale for dyspareunia included;

        -  Validated sexual dysfunction assessment questionnaire for Portuguese: Female Sexual
           Function Index (FSFI) .

        -  Quality of life questionnaire SF-36.

      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). The evaluations and sessions of Epi-No will be
      individual and will take place in the research laboratory of the physiotherapy outpatient
      clinic of the University Hospital of Londrina.

      The protocol was developed by a group of researchers based on the suggestions of already
      developed studies and clinical practice. 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.

      After the procedure the pregnant woman sits on the ball and performs some contractions of
      perineum to relieve the eventual sensation of burning.
    

Intervention name(s): Epino
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): perineal preparation
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pelvic floor; Epino; Birth; Sexual Function; Continence; Perineum