Clinical trial NCT03241524: Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
Official title: Consistency of Three Different Questionnaires to Evaluating Sexual Functions in Young Healthy Women Before and After a Pelvic Floor Muscle Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Physical Activity
Keywords: Pelvic Floor muscles
Physical Therapy
Sexual function evaluation
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 31
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility 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.

Primary outcomes:
measure: Assessment of female sexual response by Female Sexual Function Inventory (FSFI)
timeFrame: 8 weeks
measure: Assessment of female sexual response by Sexual quotient for women (QS-F)
timeFrame: 8 weeks
measure: Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female.
timeFrame: 8 weeks
Secondary outcomes:
measure: Pelvic floor muscles performance quantified by PERFECT method
timeFrame: 8 weeks
measure: Pelvic floor muscles performance quantified by PERITRON method
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Joao Pessoa
country: Brazil
facility: Laboratory of Physical Therapy
state: PB
Study officials:
References:
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.
citation: da Costa CKL, Spyrides MHC, de Sousa MBC. Consistency of three different questionnaires for evaluating sexual function in healthy young women. BMC Womens Health. 2018 Dec 20;18(1):204. doi: 10.1186/s12905-018-0693-y.