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Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women

Primary Purpose

Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise program for pelvic muscle floor
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Dysfunction, Physiological focused on measuring Pelvic Floor muscles, Physical Therapy, Sexual function evaluation

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Laboratory of Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise program for pelvic muscle floor

Arm 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.

Outcomes

Primary Outcome Measures

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

Pelvic floor muscles performance quantified by PERFECT method
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
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.

Full Information

First Posted
March 29, 2017
Last Updated
August 2, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03241524
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2016 (Actual)
Primary Completion Date
June 20, 2016 (Actual)
Study Completion Date
September 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Physical Activity
Keywords
Pelvic Floor muscles, Physical Therapy, Sexual function evaluation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program for pelvic muscle floor
Arm Type
Experimental
Arm 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(s)
Exercise program for pelvic muscle floor
Intervention 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.
Primary Outcome Measure Information:
Title
Assessment of female sexual response by Female Sexual Function Inventory (FSFI)
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.
Time Frame
8 weeks
Title
Assessment of female sexual response by Sexual quotient for women (QS-F)
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.
Time Frame
8 weeks
Title
Assessment of female sexual response by Golombok-Rust Inventory of Sexual Satisfaction (GRISS) for female.
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pelvic floor muscles performance quantified by PERFECT method
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.
Time Frame
8 weeks
Title
Pelvic floor muscles performance quantified by PERITRON method
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Laboratory of Physical Therapy
City
Joao Pessoa
State/Province
PB
ZIP/Postal Code
58038-10
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
23745356
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.
Results Reference
result
PubMed Identifier
30572853
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.
Results Reference
derived

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Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women

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