DyspareuniaNCT05282160
The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.
A study testing Epino in people with Dyspareunia and Urinary Incontinence, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dyspareunia, Urinary Incontinence, Perineal Tear
- What is being tested?
- Epino
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jan 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparous women over 18 years of age, attended by the Basic Health Units of the central region of Londrina.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function in Women 6 Months After Delivery.
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.
Read the 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.
- Conditions
- Dyspareunia, Urinary Incontinence, Perineal Tear, Perineal Injury, Episiotomy Wound, Episiotomy; Complications
- Being tested
- Epino
- Keywords
- Pelvic floor, Epino, Birth, Sexual Function, Continence, Perineum
- Medical subject headings
- Dyspareunia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinoDevice
Also called perineal preparation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Epino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence questionnaire
score of validated questionnaire
Measured: 6 months after delivery
Dyspareunia questionnaire
score of validated questionnaire
Measured: 6 months after delivery
Secondary outcomes (2)
Pelvic floor strength
number measured by intravaginal perineometry
Measured: 6 months after delivery
Quality of life score
score of validated questionnaire
Measured: 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Jan 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SILVIO HM ALMEIDA, DOCTOR, Study chair, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282160
- Sponsor's protocol ID
- ULondrina1
- Status last verified
- Nov 2020
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function in Women 6 Months After Delivery.
- ClinicalTrials.gov ID
- NCT05282160
- Acronym / sponsor ID
- ULondrina1
- Conditions
- Dyspareunia, Urinary Incontinence, Perineal Tear, Perineal Injury, Episiotomy Wound, Episiotomy; Complications
- Keywords
- Pelvic floor, Epino, Birth, Sexual Function, Continence, Perineum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: EpinoThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparous women over 18 years of age, attended by the Basic Health Units of the central region of Londrina.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpinoAlso: perineal preparationThe 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. | Device | Epino Group |
Primary outcome
Urinary Incontinence questionnaire
Time frame: 6 months after delivery
score of validated questionnaire
Dyspareunia questionnaire
Time frame: 6 months after delivery
score of validated questionnaire
2 secondary outcomes
Pelvic floor strength
Time frame: 6 months after delivery
Quality of life score
Time frame: 6 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SILVIO HM ALMEIDA, DOCTOR study chair
State University of Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epino in people with Dyspareunia and Urinary Incontinence, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Incontinence questionnaire (time frame: 6 months after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.