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Trial record 1 of 1 for:    NCT03241524 | sexual dysfunction
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Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women

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ClinicalTrials.gov Identifier: NCT03241524
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Christiane Kelen Lucena da Costa, Universidade Federal do Rio Grande do Norte

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Physical Activity Other: Exercise program for pelvic muscle floor Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Consistency of Three Different Questionnaires to Evaluating Sexual Functions in Young Healthy Women Before and After a Pelvic Floor Muscle Training Program
Actual Study Start Date : March 12, 2016
Actual Primary Completion Date : June 20, 2016
Actual Study Completion Date : September 12, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise program for pelvic muscle floor
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.
Other: Exercise program for pelvic muscle floor
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.




Primary Outcome Measures :
  1. Assessment of female sexual response by Female Sexual Function Inventory (FSFI) [ Time Frame: 8 weeks ]
    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.

  2. Assessment of female sexual response by Sexual quotient for women (QS-F) [ Time Frame: 8 weeks ]
    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.

  3. Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female. [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Pelvic floor muscles performance quantified by PERFECT method [ Time Frame: 8 weeks ]
    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.

  2. Pelvic floor muscles performance quantified by PERITRON method [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 19 and 35 years;
  • heterosexual with active sex life, living in a stable relationship for at least 6 months;
  • no pregnancy or parturition in the last 6 months;
  • clinically healthy;
  • agreeing with the terms for participating in the study;
  • To sign and agree with their informed consent to take part in the study.

Exclusion Criteria:

- Do not continue with the intervention program.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241524


Locations
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Brazil
Laboratory of Physical Therapy
Joao Pessoa, PB, Brazil, 58038-10
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte

Publications of Results:
Other Publications:
Sacomori C, Virtuoso JF, Kruger AP, Cardoso FL. [Pelvic floor muscle strength and sexual function in women]. Fisioterapia e Movimento, 28, 657-665, 2015.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christiane Kelen Lucena da Costa, Graduate student, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03241524     History of Changes
Other Study ID Numbers: 28032017
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christiane Kelen Lucena da Costa, Universidade Federal do Rio Grande do Norte:
Pelvic Floor muscles
Physical Therapy
Sexual function evaluation

Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female