Sexual BehaviorNCT02866292
The Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous
An observational study of Sexual Behavior, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Pelvic floor muscle and sexual function evaluation
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Aug 2016
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The sample consisted of 154 women divided into two groups: the first of pregnant women, formed by 76 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 78 non-pregnant nulliparous.
Who may be able to join
- Be non-pregnant nulliparous or primigravid women with pregnant only one fetus alive and without abnormalities that could increase uterine volume
- Present ability to contract the pelvic floor muscles
- Report at least one sexual relationship in the four weeks prior to data collection
Who cannot join
- Were previous urogynecological surgery history
- Non-pregnant nulliparous who did not have sexual intercourse with vaginal penetration
- Presence of cognitive impairment or neurological condition that could affect muscle activation
- Present urinary tract infection at the time of data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There Relationship Between the Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous?
This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters.
Read the detailed description
This is an observational cross-sectional study. The sample consisted of 161 women divided into two groups: the first of pregnant women, formed by 81 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 80 non-pregnant nulliparous. All participants signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (nº 145.623/2012).
To estimate the average strength of vaginal palpation and vaginal squeeze pressure in primigravid, the investigators used the following equation to scale the sample: Zα/2 refers to the probability (α/2) standard one-tailed normal distribution; σ2 is the variance associated with vaginal palpation and vaginal squeeze pressure; ε is the sampling error. Based on a similar study, which evaluated similar population, it was assumed: α=0.05, σ=1.34 and ε=0.32 for vaginal palpation; and it was assumed: α=0.05, σ=12.60 and ε=3.00 for vaginal squeeze pressure. Therefore, the sample size would be 67 and 68 women, respectively.
The PFM assessment
PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. These methods are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity.
The same examiner conducted all evaluations and before the start of the study, the reproducibility was tested. Ten women were evaluated twice, with an interval of one week to determine the intraclass correlation coefficient (ICC) of all variables.
The participants were asked about the health history. After checking that they were eligible to participate in the survey, participants were invited to empty the bladder and to remain in the supine position with hips and knees flexed and feet propped. Assessments began after explaining how to perform the contraction of PFM and the volunteer was advised to stay relaxed and breathing normally. The vaginal palpation was always the first exam to check the PFM contraction ability and then was held vaginal squeeze pressure exam.
During vaginal palpation the examiner quantified strength. The physiotherapist introduced the index and middle fingers about 4cm 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, with varies from zero (absence of muscle contraction) to five (strong contraction with finger sucking of the evaluator). To be considered valid, the movement of cranial elevation was observed by the examiner, as well as the absence of visible contractions of the adductor muscles of the hip, gluteus or abdominals.
The vaginal squeeze pressure was measured through perineometer 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. To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced approximately 4cm into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. For statistical analysis, the investigators used the mean of three peak pressures provided by the equipment.
Sexual function assessment
Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire, with a validated Portuguese version, which has an easy to understand language and subsequently was applied exclusively in Brazilian pregnant women. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The score for each question is individual, varying from 0 to 6 points. The investigators performed a mathematical calculation, which allowed the acquisition of a final index, the total score of the FSFI. The total score of FSFI ranges between 2 and 36 points. The lower the score, the worse is the sexual function is. The assessment is for the period of the last four weeks.
At the time of the interview, the pregnant women were instructed regarding the completion and they had their enough time to fill it out in a self-administered way in a reserved place.
Statistical analysis
Statistical analysis was performed using Statistical Package for Social Sciences software (SPSSV21, Chicago, IL). Data normality was tested by the Kolmogorov-Smirnov test. To perform the variables comparison, the Mann-Whitney test was performed. To verify the correlation between the variables, the Spearman correlation test was used. Values of p<0.05 were considered significant. The intensity of the relationship of the correlation coefficient values were interpreted according to the following guidelines: 0 = zero; 0.10-0.39 = weak; 0.40-0.69 = moderate; 0.70-0.99 = strong, 1 = perfect, regardless of whether positive or negative.
- Conditions
- Sexual Behavior
- Being tested
- Pelvic floor muscle and sexual function evaluation
- Keywords
- Pelvic Floor, Pregnancy, Physical Therapy Specialty
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle and sexual function evaluationOther
PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM. Muscle function was classified by the Oxford Scale Modified.
The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them.
Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain.
| Study group | Role | What they receive |
|---|---|---|
| non-pregnant nulliparous | Nulliparous without previous gestation. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire. Receives: Other: Pelvic floor muscle and sexual function evaluation | |
| primigravid | Pregnant women on her first pregnancy and gestational age above 14 weeks. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire. Receives: Other: Pelvic floor muscle and sexual function evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength with Oxford scale
Measured: through study completion, an average of 1 year
score of Female Sexual Function Index questionnaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies 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
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marília Duarte dos Santos, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866292
- Sponsor's protocol ID
- CEP UFU 145.623/2012
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pereira VS, Hirakawa HS, Oliveira AB, Driusso P. Relationship among vaginal palpation, vaginal squeeze pressure, electromyographic and ultrasonographic variables of female pelvic floor muscles. Braz J Phys Ther. 2014 Sep-Oct;18(5):428-34. doi: 10.1590/bjpt-rbf.2014.0038. Epub 2014 Oct 10.
PubMed 25372005Bo K, Finckenhagen HB. Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure. Acta Obstet Gynecol Scand. 2001 Oct;80(10):883-7. doi: 10.1034/j.1600-0412.2001.801003.x.
PubMed 11580731Arab AM, Behbahani RB, Lorestani L, Azari A. Correlation of digital palpation and transabdominal ultrasound for assessment of pelvic floor muscle contraction. J Man Manip Ther. 2009;17(3):e75-9. doi: 10.1179/jmt.2009.17.3.75E.
PubMed 20046616
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Relationship Between the Pelvic Floor Muscles Strength and Sexual Function in Primigravid and Non-pregnant Nulliparous?
- ClinicalTrials.gov ID
- NCT02866292
- Acronym / sponsor ID
- CEP UFU 145.623/2012
- Conditions
- Sexual Behavior
- Keywords
- Pelvic Floor, Pregnancy, Physical Therapy Specialty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Aug 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.
This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters.
Detailed description
This is an observational cross-sectional study. The sample consisted of 161 women divided into two groups: the first of pregnant women, formed by 81 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 80 non-pregnant nulliparous. All participants signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (nº 145.623/2012).
To estimate the average strength of vaginal palpation and vaginal squeeze pressure in primigravid, the investigators used the following equation to scale the sample: Zα/2 refers to the probability (α/2) standard one-tailed normal distribution; σ2 is the variance associated with vaginal palpation and vaginal squeeze pressure; ε is the sampling error. Based on a similar study, which evaluated similar population, it was assumed: α=0.05, σ=1.34 and ε=0.32 for vaginal palpation; and it was assumed: α=0.05, σ=12.60 and ε=3.00 for vaginal squeeze pressure. Therefore, the sample size would be 67 and 68 women, respectively.
The PFM assessment
PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. These methods are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity.
The same examiner conducted all evaluations and before the start of the study, the reproducibility was tested. Ten women were evaluated twice, with an interval of one week to determine the intraclass correlation coefficient (ICC) of all variables.
The participants were asked about the health history. After checking that they were eligible to participate in the survey, participants were invited to empty the bladder and to remain in the supine position with hips and knees flexed and feet propped. Assessments began after explaining how to perform the contraction of PFM and the volunteer was advised to stay relaxed and breathing normally. The vaginal palpation was always the first exam to check the PFM contraction ability and then was held vaginal squeeze pressure exam.
During vaginal palpation the examiner quantified strength. The physiotherapist introduced the index and middle fingers about 4cm 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, with varies from zero (absence of muscle contraction) to five (strong contraction with finger sucking of the evaluator). To be considered valid, the movement of cranial elevation was observed by the examiner, as well as the absence of visible contractions of the adductor muscles of the hip, gluteus or abdominals.
The vaginal squeeze pressure was measured through perineometer 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. To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced approximately 4cm into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. For statistical analysis, the investigators used the mean of three peak pressures provided by the equipment.
Sexual function assessment
Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire, with a validated Portuguese version, which has an easy to understand language and subsequently was applied exclusively in Brazilian pregnant women. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The score for each question is individual, varying from 0 to 6 points. The investigators performed a mathematical calculation, which allowed the acquisition of a final index, the total score of the FSFI. The total score of FSFI ranges between 2 and 36 points. The lower the score, the worse is the sexual function is. The assessment is for the period of the last four weeks.
At the time of the interview, the pregnant women were instructed regarding the completion and they had their enough time to fill it out in a self-administered way in a reserved place.
Statistical analysis
Statistical analysis was performed using Statistical Package for Social Sciences software (SPSSV21, Chicago, IL). Data normality was tested by the Kolmogorov-Smirnov test. To perform the variables comparison, the Mann-Whitney test was performed. To verify the correlation between the variables, the Spearman correlation test was used. Values of p<0.05 were considered significant. The intensity of the relationship of the correlation coefficient values were interpreted according to the following guidelines: 0 = zero; 0.10-0.39 = weak; 0.40-0.69 = moderate; 0.70-0.99 = strong, 1 = perfect, regardless of whether positive or negative.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-pregnant nulliparous | – | Other: Pelvic floor muscle and sexual function evaluationNulliparous without previous gestation. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire. |
| primigravid | – | Other: Pelvic floor muscle and sexual function evaluationPregnant women on her first pregnancy and gestational age above 14 weeks. Pelvic floor muscle evaluation by means of vaginal palpation and vaginal squeeze pressure (perineometer), and evaluation of the sexual function by the Female Sexual Function Index (FSFI) questionnaire. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample consisted of 154 women divided into two groups: the first of pregnant women, formed by 76 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 78 non-pregnant nulliparous.
Key inclusion criteria (3 listed)
- Be non-pregnant nulliparous or primigravid women with pregnant only one fetus alive and without abnormalities that could increase uterine volume
- Present ability to contract the pelvic floor muscles
- Report at least one sexual relationship in the four weeks prior to data collection
Key exclusion criteria (4 listed)
- Were previous urogynecological surgery history
- Non-pregnant nulliparous who did not have sexual intercourse with vaginal penetration
- Presence of cognitive impairment or neurological condition that could affect muscle activation
- Present urinary tract infection at the time of data collection.
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 and sexual function evaluationPFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM. Muscle function was classified by the Oxford Scale Modified. The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain. | Other | non-pregnant nulliparous, primigravid |
Primary outcome
muscle strength with Oxford scale
Time frame: through study completion, an average of 1 year
score of Female Sexual Function Index questionnaire
Time frame: through study completion, an average of 1 year
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 15 Aug 2016.
- Background: PubMed 25372005Pereira VS, Hirakawa HS, Oliveira AB, Driusso P. Relationship among vaginal palpation, vaginal squeeze pressure, electromyographic and ultrasonographic variables of female pelvic floor muscles. Braz J Phys Ther. 2014 Sep-Oct;18(5):428-34. doi: 10.1590/bjpt-rbf.2014.0038. Epub 2014 Oct 10.
- Results publication: PubMed 11580731Bo K, Finckenhagen HB. Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure. Acta Obstet Gynecol Scand. 2001 Oct;80(10):883-7. doi: 10.1034/j.1600-0412.2001.801003.x.
- Results publication: PubMed 20046616Arab AM, Behbahani RB, Lorestani L, Azari A. Correlation of digital palpation and transabdominal ultrasound for assessment of pelvic floor muscle contraction. J Man Manip Ther. 2009;17(3):e75-9. doi: 10.1179/jmt.2009.17.3.75E.
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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.
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 Sexual Behavior, run by Federal University of Uberlandia 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 4 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 15 Aug 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?
muscle strength with Oxford scale (time frame: through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT02866292, which also lists 3 linked publications.
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 15 Aug 2016.