<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241524</url>
  </required_header>
  <id_info>
    <org_study_id>28032017</org_study_id>
    <nct_id>NCT03241524</nct_id>
  </id_info>
  <brief_title>Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women</brief_title>
  <official_title>Consistency of Three Different Questionnaires to Evaluating Sexual Functions in Young Healthy Women Before and After a Pelvic Floor Muscle Training Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The sample comprised 31 female undergraduate students attending a private University in João&#xD;
      Pessoa, northeastern Brazil. The inclusion criteria were: age between 19 and 35 years,&#xD;
      heterosexual, active sex life, living in a stable relationship for at least 6 months no&#xD;
      pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms&#xD;
      for participating in the study. All participants gave their informed consent to take part in&#xD;
      the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE: To compare the consistency of 3 instruments for sexual function evaluation in&#xD;
      healthy young women before and after a pelvic floor muscle training. Methods: Thirty-one&#xD;
      healthy young women were enrolled in an 8-week training program, consisting of bipedal&#xD;
      exercises performed at home. The PERFECT and Peritron methods were used to estimate the&#xD;
      efficacy of the intervention on pelvic muscles. Three questionnaires (FSFI, SQ-F and GRISS)&#xD;
      were applied to assess sexual function. Both procedures were performed on three occasions:&#xD;
      before, 4 and 8 weeks after the start of the training program. ANOVA for repeat measures and&#xD;
      Tukey's post hoc were applied to analyze PERFECT and Peritron results, as well as individual&#xD;
      domains and total scores of the questionnaires. The accuracy measured by the area under the&#xD;
      ROC curve (AUC) for individual domains of each questionnaire and cross-validated pairwise&#xD;
      comparison of the three instruments were also analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2016</start_date>
  <completion_date type="Actual">September 12, 2016</completion_date>
  <primary_completion_date type="Actual">June 20, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Perineal floor muscle performance and participants' sexual functions were evaluated in three successive situations: (1) Initial evaluation; (2) after 4 weeks (intermediate evaluation), and (3) 8 weeks (final evaluation) from the start of the training program.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of female sexual response by Female Sexual Function Inventory (FSFI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>This questionnaire contains 19 itens assessing sexual function over the past four weeks, associated with six domains and possible types of disorders: desire, arousal, lubrification, orgasm, satisfaction of sexual life, and pain during or after the intercourse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of female sexual response by Sexual quotient for women (QS-F)</measure>
    <time_frame>8 weeks</time_frame>
    <description>This instrument is composed of 10 questions that assess sexual function, adressing desire and interest in sex, foreplay, sexual arousal and harmony with the partner, comfort in sexual intercourse, and orgasm and sexual satisfaction. The overall scores range from 0 to 100, where high scores mean excellent sexual performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female.</measure>
    <time_frame>8 weeks</time_frame>
    <description>The GRISS is a 28-item questionnaire that provides a total GRISS score as well as two separate scales for males and females. For females, the scale has 8 items, including anorgasmia, vaginismus, non-communication, infrequency, female avoidance, female non-sensuality, female dissatisfaction and anorgasmia. Scoring was from 0 to 10 with values higher than 5 indicating sexual dysfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor muscles performance quantified by PERFECT method</measure>
    <time_frame>8 weeks</time_frame>
    <description>This method is an acronym for the evaluation of contractile components of the pelvic floor muscles and was validated with high test-retest reliability, producing significant correlations for the variables, in particular, power and endurance. According to definitions of these methods, P indicates power or pressure, which corresponds to muscle strength estimated by manometry biofeedback or digital touch during voluntary maximum contraction. The evaluation is based on Oxford modified scale: Degrees: 0 - no perineal contraction visible or by palpation (non-contraction); 1- no perineal contraction visible, recognized only by palpation; 2 - weak perineal contraction to palpation; 3 - perineal contraction present, but with nonresistance to palpation; 4 - perineal contraction present with counter-resistance to palpation of less than 5 seconds ; and 5 - perineal contraction present with counter-resistance to palpation of more than 5 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor muscles performance quantified by PERITRON method</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Peritron is a hand-held clinical biofeedback perineometer used for assessing the strength of the pelvic floor muscles. The device helps teach patients how to effectively perform pelvic floor exercises (kegels). Pelvic floor contraction causes air pressure in the sensor to be transferred through the connecting tube and displayed on the readout unit.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Sexual Dysfunction, Physiological</condition>
  <condition>Sexual Dysfunctions, Psychological</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Exercise program for pelvic muscle floor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training program for pelvic muscles and application of 3 questionnaires for sexual function evaluation and the use of PERFECT and Perina methods to evaluate perineal musculature.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise program for pelvic muscle floor</intervention_name>
    <description>Pelvic muscles of each participant was evaluated by PERFECT and Peritron methods in terms of strengthening as well as sexual function response using 3 questionnaires, before and after 4 and 8 weeks from the beggining of an exercise program prescribed according to individual ratings obtained in the previous evaluation.</description>
    <arm_group_label>Exercise program for pelvic muscle floor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 19 and 35 years;&#xD;
&#xD;
          -  heterosexual with active sex life, living in a stable relationship for at least 6&#xD;
             months;&#xD;
&#xD;
          -  no pregnancy or parturition in the last 6 months;&#xD;
&#xD;
          -  clinically healthy;&#xD;
&#xD;
          -  agreeing with the terms for participating in the study;&#xD;
&#xD;
          -  To sign and agree with their informed consent to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Do not continue with the intervention program.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laboratory of Physical Therapy</name>
      <address>
        <city>Joao Pessoa</city>
        <state>PB</state>
        <zip>58038-10</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Sacomori C, Virtuoso JF, Kruger AP, Cardoso FL. [Pelvic floor muscle strength and sexual function in women]. Fisioterapia e Movimento, 28, 657-665, 2015.</citation>
  </reference>
  <results_reference>
    <citation>Damjanovic A, Duisin D, Barisic J. The evolution of the female sexual response concept: treatment implications. Srp Arh Celok Lek. 2013 Mar-Apr;141(3-4):268-74. doi: 10.2298/sarh1304268d.</citation>
    <PMID>23745356</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Christiane Kelen Lucena da Costa</investigator_full_name>
    <investigator_title>Graduate student</investigator_title>
  </responsible_party>
  <keyword>Pelvic Floor muscles</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Sexual function evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexual Dysfunction, Physiological</mesh_term>
    <mesh_term>Sexual Dysfunctions, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241524
org study id: 28032017
nct id: NCT03241524
lead sponsor: 
has dmc: Yes
is fda regulated device: No
The sample comprised 31 female undergraduate students attending a private University in João
      Pessoa, northeastern Brazil. The inclusion criteria were: age between 19 and 35 years,
      heterosexual, active sex life, living in a stable relationship for at least 6 months no
      pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms
      for participating in the study. All participants gave their informed consent to take part in
      the study.
PURPOSE: To compare the consistency of 3 instruments for sexual function evaluation in
      healthy young women before and after a pelvic floor muscle training. Methods: Thirty-one
      healthy young women were enrolled in an 8-week training program, consisting of bipedal
      exercises performed at home. The PERFECT and Peritron methods were used to estimate the
      efficacy of the intervention on pelvic muscles. Three questionnaires (FSFI, SQ-F and GRISS)
      were applied to assess sexual function. Both procedures were performed on three occasions:
      before, 4 and 8 weeks after the start of the training program. ANOVA for repeat measures and
      Tukey's post hoc were applied to analyze PERFECT and Peritron results, as well as individual
      domains and total scores of the questionnaires. The accuracy measured by the area under the
      ROC curve (AUC) for individual domains of each questionnaire and cross-validated pairwise
      comparison of the three instruments were also analyzed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Perineal floor muscle performance and participants' sexual functions were evaluated in three successive situations: (1) Initial evaluation; (2) after 4 weeks (intermediate evaluation), and (3) 8 weeks (final evaluation) from the start of the training program.
primary purpose: Prevention
masking: None (Open Label)
measure: Assessment of female sexual response by Female Sexual Function Inventory (FSFI)
time frame: 8 weeks
description: This questionnaire contains 19 itens assessing sexual function over the past four weeks, associated with six domains and possible types of disorders: desire, arousal, lubrification, orgasm, satisfaction of sexual life, and pain during or after the intercourse.
measure: Assessment of female sexual response by Sexual quotient for women (QS-F)
time frame: 8 weeks
description: This instrument is composed of 10 questions that assess sexual function, adressing desire and interest in sex, foreplay, sexual arousal and harmony with the partner, comfort in sexual intercourse, and orgasm and sexual satisfaction. The overall scores range from 0 to 100, where high scores mean excellent sexual performance.
measure: Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female.
time frame: 8 weeks
description: The GRISS is a 28-item questionnaire that provides a total GRISS score as well as two separate scales for males and females. For females, the scale has 8 items, including anorgasmia, vaginismus, non-communication, infrequency, female avoidance, female non-sensuality, female dissatisfaction and anorgasmia. Scoring was from 0 to 10 with values higher than 5 indicating sexual dysfunction.
measure: Pelvic floor muscles performance quantified by PERFECT method
time frame: 8 weeks
description: This method is an acronym for the evaluation of contractile components of the pelvic floor muscles and was validated with high test-retest reliability, producing significant correlations for the variables, in particular, power and endurance. According to definitions of these methods, P indicates power or pressure, which corresponds to muscle strength estimated by manometry biofeedback or digital touch during voluntary maximum contraction. The evaluation is based on Oxford modified scale: Degrees: 0 - no perineal contraction visible or by palpation (non-contraction); 1- no perineal contraction visible, recognized only by palpation; 2 - weak perineal contraction to palpation; 3 - perineal contraction present, but with nonresistance to palpation; 4 - perineal contraction present with counter-resistance to palpation of less than 5 seconds ; and 5 - perineal contraction present with counter-resistance to palpation of more than 5 seconds.
measure: Pelvic floor muscles performance quantified by PERITRON method
time frame: 8 weeks
description: The Peritron is a hand-held clinical biofeedback perineometer used for assessing the strength of the pelvic floor muscles. The device helps teach patients how to effectively perform pelvic floor exercises (kegels). Pelvic floor contraction causes air pressure in the sensor to be transferred through the connecting tube and displayed on the readout unit.
arm group label: Exercise program for pelvic muscle floor
arm group type: Experimental
description: Training program for pelvic muscles and application of 3 questionnaires for sexual function evaluation and the use of PERFECT and Perina methods to evaluate perineal musculature.
intervention type: Other
intervention name: Exercise program for pelvic muscle floor
description: Pelvic muscles of each participant was evaluated by PERFECT and Peritron methods in terms of strengthening as well as sexual function response using 3 questionnaires, before and after 4 and 8 weeks from the beggining of an exercise program prescribed according to individual ratings obtained in the previous evaluation.
arm group label: Exercise program for pelvic muscle floor
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
citation: Sacomori C, Virtuoso JF, Kruger AP, Cardoso FL. [Pelvic floor muscle strength and sexual function in women]. Fisioterapia e Movimento, 28, 657-665, 2015.
citation: Damjanovic A, Duisin D, Barisic J. The evolution of the female sexual response concept: treatment implications. Srp Arh Celok Lek. 2013 Mar-Apr;141(3-4):268-74. doi: 10.2298/sarh1304268d.
PMID: 23745356
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Christiane Kelen Lucena da Costa
investigator title: Graduate student
mesh term: Sexual Dysfunction, Physiological
mesh term: Sexual Dysfunctions, Psychological
sharing ipd: No