Correlation of Pelvic Floor Muscle Evaluation MethodsNCT02831452
Relationship Among Vaginal Palpation, Vaginal Squeeze Pressure and Dynamometry of Nulliparous Pelvic Floor Muscles
An observational study of Correlation of Pelvic Floor Muscle Evaluation Methods, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to determine if there is a correlation between digital palpation, perineometry and dynamometry as PFM function evaluation methods in nulliparous without pelvic floor dysfunction. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Correlation of Pelvic Floor Muscle Evaluation Methods
- What is being tested?
- pelvic floor muscle strength evaluation
- How many people
- 141 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Jul 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: healthy women without previous labor and delivery - non-pregnant or in their first pregnancy
Who may be able to join
- never have passed for childbirth situation
- ability to contract correctly the PFM
- without urogynecological complaints
Who cannot join
- history of previous pelvic surgery
- without previous sexual intercourse
- present neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine if there is a correlation between digital palpation, perineometry and dynamometry as PFM function evaluation methods in nulliparous without pelvic floor dysfunction.
Read the detailed description
Study design - this study was conducted in Cinesiofunctional Performance Laboratory Pelvic and Women's Health at the Federal University of Uberlandia (UFU), the volunteers were recruited from December 2014 to July 2015. This is an observational, cross-sectional and comparative study, the sample consisted of 141 nulliparous women (non-pregnant nulliparous or primigravids). All volunteer shave signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (No.1067162/2014). Female students of UFU were invited by personal contact to participate in the study. The primigravids were participants in the Prenatal Program of the public health system in Uberlandia city and they have also been invited by personal contact. Inclusion criterion for volunteers were: never have passed for childbirth situation,ability to contract correctly the PFM and without urogynecological complaints. Exclusion criterion were: history of previous pelvic surgery, without previous sexual intercourse, and present neuromuscular diseases. The experient examiner, with expertise in PFM evaluation conducted the evaluations. After checking that they were eligible to participate in the survey, participants were asked to empty the bladder and to remain in the supine position on an appropriate bed with hips and knees flexed and maintaining the lumbar spine in neutral position.The PFM assessment was performed by vaginal palpation, vaginal squeeze pressure and dynamometry. The vaginal palpation and vaginal squeeze pressure are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity(10, 11, 12, 13). The measurements performed with a dynamometer in this study were similar to the study of Martinho et al(4) which used the same instrument and have demonstrated reproducibility of the assessment method. During all PFM assessments, the volunteer was advised to stay relaxed and breathing normally. To be considered valid, the cranial elevation movement was observed by the examiner, as well as the absence of visible contractions of the adductor, muscles of the hip, gluteal muscles or abdominals. Strong verbal command was adopted to request the PFM contraction in all exams.
Assessments began after explaining how to perform the PFM contraction. The vaginal palpation was always the first exam to check the PFM contraction ability and then the order of vaginal squeeze pressure exam and dynamometry was randomized.
The PFM assessment by digital palpation was performed as proposed by Laycock and Jerwood. The physiotherapist introduced the index and middle fingers about 4 cm inside the vagina, and requested to hold the maximum contraction of the PFM, according to the instruction of a movement "inward and up" with the greatest possible strength. Muscle function was classified by the Oxford Scale Modified, which varies from zero (absence of muscle contraction) to five (strong contraction). The vaginal squeeze pressure was measured through Peritron equipment (Cardio Design Pty Ltd, Oakleigh, Victoria, Australia) equipped with a vaginal probe that has been covered with a non-lubricated condom and then the probe was lubricated with hypoallergenic gel. The probe sensor was connected to a microprocessor hand with a latex tube, which allows the measurement of nip pressure in centimeters of water (cmH2O). To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced approximately 3.5cm into the vaginal cavity. Then the device was inflated to 100cmH2O (calibration). The female volunteers were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. The correct contraction was checked visually by the physiotherapist. All volunteers were instructed to avoid using the abdominal muscles, gluteal and hip adductor. For statistical analysis, the investigator used the peak pressure provided by the equipment. The PFM contraction strength was assessed by vaginal dynamometer EMG System do Brasil (model DFV 020.101/10). It is cylindrical in shape (9.5 cm in length and 3.3 cm in diameter), made of steel and is equipped with a load cell 2 cm from its base, which can measure anteroposterior unidirectional compressive strength in Kg/force (Kgf). The equipment was previously coated with a condom and lubricated with hypoallergenic gel, which was inserted into the vaginal cavity with the load cell positioned so that it could capture the anteroposterior compression strength. The participant was asked to perform three maximal voluntary PFM contractions for eight seconds with a rest period of 30 seconds between the contractions. The same precautions for correct contraction were adopted. The best value of maximum strength (difference between the highest and lowest strength in Kgf) was used for statistical analysis. Statistical analysis was performed using Statistical Package for Social Sciences software (SPSSV17, Chicago, IL). Data normality was tested by the Shapiro-Wilk test.
To verify the correlation between the variables, the Pearson correlation test was used. Values of p < 0.05 were considered significant. The correlation values were interpreted according to the following guidelines: 0.00 - 0.19= no to slight; 0.20-0.39= mild; 0.40-0.69= moderate; 0.70-0.89= high and 0.90-1.00= very high. Data were expressed as mean and standard deviation (SD).
- Being tested
- pelvic floor muscle strength evaluation
- Keywords
- pelvic floor muscles, evaluation, dynamometer, perineometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle strength evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| non-pregnant nulliparous | nulliparous without previous gestation. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. Receives: Other: pelvic floor muscle strength evaluation | |
| primigravid on 1º trimester | nulliparous women on her first pregnancy and gestational age until 13 weeks and 6 days.
Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. Receives: Other: pelvic floor muscle strength evaluation | |
| primigravid on 2º trimester | nulliparous women on her first pregnancy and gestational age between 14 weeks and 27 weeks.
Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. Receives: Other: pelvic floor muscle strength evaluation | |
| primigravid on 3º trimester | nulliparous women on her first pregnancy and gestational age above 28 weeks. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. Receives: Other: pelvic floor muscle strength evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between pelvic floor muscle strength evaluation methods
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correlation of Pelvic Floor Muscle Evaluation MethodsStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Magalhães Resende, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831452
- Sponsor's protocol ID
- 1061162/2014 CEP/UFU
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Among Vaginal Palpation, Vaginal Squeeze Pressure and Dynamometry of Nulliparous Pelvic Floor Muscles
- ClinicalTrials.gov ID
- NCT02831452
- Acronym / sponsor ID
- 1061162/2014 CEP/UFU
- Keywords
- pelvic floor muscles, evaluation, dynamometer, perineometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
The aim of this study is to determine if there is a correlation between digital palpation, perineometry and dynamometry as PFM function evaluation methods in nulliparous without pelvic floor dysfunction.
Detailed description
Study design - this study was conducted in Cinesiofunctional Performance Laboratory Pelvic and Women's Health at the Federal University of Uberlandia (UFU), the volunteers were recruited from December 2014 to July 2015. This is an observational, cross-sectional and comparative study, the sample consisted of 141 nulliparous women (non-pregnant nulliparous or primigravids). All volunteer shave signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (No.1067162/2014). Female students of UFU were invited by personal contact to participate in the study. The primigravids were participants in the Prenatal Program of the public health system in Uberlandia city and they have also been invited by personal contact. Inclusion criterion for volunteers were: never have passed for childbirth situation,ability to contract correctly the PFM and without urogynecological complaints. Exclusion criterion were: history of previous pelvic surgery, without previous sexual intercourse, and present neuromuscular diseases. The experient examiner, with expertise in PFM evaluation conducted the evaluations. After checking that they were eligible to participate in the survey, participants were asked to empty the bladder and to remain in the supine position on an appropriate bed with hips and knees flexed and maintaining the lumbar spine in neutral position.The PFM assessment was performed by vaginal palpation, vaginal squeeze pressure and dynamometry. The vaginal palpation and vaginal squeeze pressure are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity(10, 11, 12, 13). The measurements performed with a dynamometer in this study were similar to the study of Martinho et al(4) which used the same instrument and have demonstrated reproducibility of the assessment method. During all PFM assessments, the volunteer was advised to stay relaxed and breathing normally. To be considered valid, the cranial elevation movement was observed by the examiner, as well as the absence of visible contractions of the adductor, muscles of the hip, gluteal muscles or abdominals. Strong verbal command was adopted to request the PFM contraction in all exams.
Assessments began after explaining how to perform the PFM contraction. The vaginal palpation was always the first exam to check the PFM contraction ability and then the order of vaginal squeeze pressure exam and dynamometry was randomized.
The PFM assessment by digital palpation was performed as proposed by Laycock and Jerwood. The physiotherapist introduced the index and middle fingers about 4 cm inside the vagina, and requested to hold the maximum contraction of the PFM, according to the instruction of a movement "inward and up" with the greatest possible strength. Muscle function was classified by the Oxford Scale Modified, which varies from zero (absence of muscle contraction) to five (strong contraction). The vaginal squeeze pressure was measured through Peritron equipment (Cardio Design Pty Ltd, Oakleigh, Victoria, Australia) equipped with a vaginal probe that has been covered with a non-lubricated condom and then the probe was lubricated with hypoallergenic gel. The probe sensor was connected to a microprocessor hand with a latex tube, which allows the measurement of nip pressure in centimeters of water (cmH2O). To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced approximately 3.5cm into the vaginal cavity. Then the device was inflated to 100cmH2O (calibration). The female volunteers were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. The correct contraction was checked visually by the physiotherapist. All volunteers were instructed to avoid using the abdominal muscles, gluteal and hip adductor. For statistical analysis, the investigator used the peak pressure provided by the equipment. The PFM contraction strength was assessed by vaginal dynamometer EMG System do Brasil (model DFV 020.101/10). It is cylindrical in shape (9.5 cm in length and 3.3 cm in diameter), made of steel and is equipped with a load cell 2 cm from its base, which can measure anteroposterior unidirectional compressive strength in Kg/force (Kgf). The equipment was previously coated with a condom and lubricated with hypoallergenic gel, which was inserted into the vaginal cavity with the load cell positioned so that it could capture the anteroposterior compression strength. The participant was asked to perform three maximal voluntary PFM contractions for eight seconds with a rest period of 30 seconds between the contractions. The same precautions for correct contraction were adopted. The best value of maximum strength (difference between the highest and lowest strength in Kgf) was used for statistical analysis. Statistical analysis was performed using Statistical Package for Social Sciences software (SPSSV17, Chicago, IL). Data normality was tested by the Shapiro-Wilk test.
To verify the correlation between the variables, the Pearson correlation test was used. Values of p < 0.05 were considered significant. The correlation values were interpreted according to the following guidelines: 0.00 - 0.19= no to slight; 0.20-0.39= mild; 0.40-0.69= moderate; 0.70-0.89= high and 0.90-1.00= very high. Data were expressed as mean and standard deviation (SD).
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-pregnant nulliparous | – | Other: pelvic floor muscle strength evaluationnulliparous without previous gestation. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. |
| primigravid on 1º trimester | – | Other: pelvic floor muscle strength evaluationnulliparous women on her first pregnancy and gestational age until 13 weeks and 6 days. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. |
| primigravid on 2º trimester | – | Other: pelvic floor muscle strength evaluationnulliparous women on her first pregnancy and gestational age between 14 weeks and 27 weeks. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. |
| primigravid on 3º trimester | – | Other: pelvic floor muscle strength evaluationnulliparous women on her first pregnancy and gestational age above 28 weeks. Pelvic floor muscle evaluation by means of vaginal palpation, vaginal squeeze pressure (perineometer), and pelvic floor muscle strength using a proper vaginal dynamometer. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- healthy women without previous labor and delivery - non-pregnant or in their first pregnancy
Key inclusion criteria (3 listed)
- never have passed for childbirth situation
- ability to contract correctly the PFM
- without urogynecological complaints
Key exclusion criteria (3 listed)
- history of previous pelvic surgery
- without previous sexual intercourse
- present neuromuscular diseases
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 |
|---|---|---|
| pelvic floor muscle strength evaluation | Other | non-pregnant nulliparous, primigravid on 1º trimester, primigravid on 2º trimester, primigravid on 3º trimester |
Primary outcome
correlation between pelvic floor muscle strength evaluation methods
Time frame: seven months
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 13 Jul 2016.
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?
An observational study of Correlation of Pelvic Floor Muscle Evaluation Methods, run by Federal University of São Paulo 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 3 inclusion and 3 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 13 Jul 2016. 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?
correlation between pelvic floor muscle strength evaluation methods (time frame: seven months). 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 13 Jul 2016.