Pelvic Floor DisordersNCT04955418
Effects of Epi-no Device on Pelvic Floor Dysfunctions
A study testing Epi-No® and Evaluation in people with Pelvic Floor Disorders 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. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia
- What is being tested?
- Epi-No® and Evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 1 Jan 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparous
- single fetus
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions
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.
- Being tested
- Epi-No®, Evaluation
- Keywords
- Epi-no device, vaginal birth
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi-No®Device
evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.
EvaluationDiagnostic test
evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.
| Study group | Role | What they receive |
|---|---|---|
| Epi-no Group | Active comparator | The study group was evaluated before the intervention (between 30 and 32 weeks) and 6 months after delivery.From the 34th week onwards, they performed 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. The pregnant woman was placed in the supine position and EPI-NO® was inserted into vaginal canal. After the introduction of the deflated tube, it was minimally inflated until the perception in the vaginal canal. The first 5 minutes were for perception of the pelvic floor with 10 contractions and relaxation of the perineum in order to maintain muscle strength. After 15 minutes for stretching the perineum, the device was gradually inflated and always respecting the pregnant woman's tolerance. After a total of 20 minutes, the pregnant woman was asked to relax the pelvic floor in order for the inflated device to gently exit her vaginal cavity. The perimeter was measured using a tape measure in its largest diameter. Receives: Device: Epi-No®; Diagnostic Test: Evaluation |
| Control Group | Placebo comparator | The control group was evaluated only once, six month after delivery. Receives: Diagnostic Test: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after delivery
Secondary outcomes (3)
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.
Measured: 6 months after delivery
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.
Measured: 6 months after delivery
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.
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 posted8 Jul 2021
- Study start1 Oct 2017
- Primary completion31 Jul 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Parallel groups
- Model description
- case-control study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955418
- Sponsor's protocol ID
- 2.219.051
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epi-no Device on Perineal Preparation and Pelvic Floor Dysfunctions
- ClinicalTrials.gov ID
- NCT04955418
- Acronym / sponsor ID
- 2.219.051
- Keywords
- Epi-no device, vaginal birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 Jul 2021 (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. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- case-control study
| Arm | Type | Receives |
|---|---|---|
| Epi-no Group | Active comparator | Device: Epi-No®, Diagnostic Test: EvaluationThe study group was evaluated before the intervention (between 30 and 32 weeks) and 6 months after delivery.From the 34th week onwards, they performed 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. The pregnant woman was placed in the supine position and EPI-NO® was inserted into vaginal canal. After the introduction of the deflated tube, it was minimally inflated until the perception in the vaginal canal. The first 5 minutes were for perception of the pelvic floor with 10 contractions and relaxation of the perineum in order to maintain muscle strength. After 15 minutes for stretching the perineum, the device was gradually inflated and always respecting the pregnant woman's tolerance. After a total of 20 minutes, the pregnant woman was asked to relax the pelvic floor in order for the inflated device to gently exit her vaginal cavity. The perimeter was measured using a tape measure in its largest diameter. |
| Control Group | Placebo comparator | Diagnostic Test: EvaluationThe control group was evaluated only once, six month after delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primiparous
- single fetus
Key exclusion criteria (8 listed)
- Patients with complaints of urinary incontinence during or before pregnancy
- hypertension and gestational diabetes
- placenta previa
- twin pregnancy
- multiparous
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 |
|---|---|---|
| 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. | Device | Epi-no Group |
| Evaluationevaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery. | Diagnostic test | Control Group, Epi-no Group |
Primary outcome
Effect of birth training with Epi-no
Time frame: 6 months after delivery
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.
3 secondary outcomes
Pelvic floor muscle strength
Time frame: 6 months after delivery
Incidence of urinary incontinence and dyspareunia
Time frame: 6 months after delivery
Incidence of dyspareunia
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 8 Jul 2021.
Related trials for Pelvic Floor Disorders
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epi-No® and Evaluation in people with Pelvic Floor Disorders 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 2 inclusion and 8 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 8 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Effect of birth training with Epi-no (time frame: 6 months after delivery). 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 8 Jul 2021.