Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women

Not Applicable

Completed

• Conditions: Physical Activity; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
• Interventions: Other: Exercise program for pelvic muscle floor

• Registration Number: NCT03241524
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-03-12
• Primary Completion: 2016-06-20
• Study Completion: 2016-09-12
• Study First Submitted: 2017-03-29
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise program for pelvic muscle floor	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.

Primary Outcome Measures

Name	Time	Method
Assessment of female sexual response by Female Sexual Function Inventory (FSFI)	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.
Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female.	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.
Assessment of female sexual response by Sexual quotient for women (QS-F)	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic floor muscles performance quantified by PERFECT method	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.
Pelvic floor muscles performance quantified by PERITRON method	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.

Trial Locations

Locations (1)

Laboratory of Physical Therapy; 🇧🇷 Joao Pessoa, PB, Brazil