Sexual Dysfunction, PhysiologicalNCT03241524
Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
A study testing Exercise program for pelvic muscle floor in people with Sexual Dysfunction, Physiological and Sexual Dysfunctions, Psychological, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Physical Activity
- What is being tested?
- Exercise program for pelvic muscle floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Mar 2016to 12 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Do not continue with the intervention program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consistency of Three Different Questionnaires to Evaluating Sexual Functions in Young Healthy Women Before and After a Pelvic Floor Muscle Training Program
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.
Read the 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.
- Being tested
- Exercise program for pelvic muscle floor
- Keywords
- Pelvic Floor muscles, Physical Therapy, Sexual function evaluation
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program for pelvic muscle floorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise program for pelvic muscle floor | Experimental | 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. Receives: Other: Exercise program for pelvic muscle floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Mar 2016
- Primary completion20 Jun 2016
- Study completion12 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunction, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Kelen Lucena da Costa, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241524
- Sponsor's protocol ID
- 28032017
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
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.
PubMed 23745356da 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.
PubMed 30572853
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency of Three Different Questionnaires to Evaluating Sexual Functions in Young Healthy Women Before and After a Pelvic Floor Muscle Training Program
- ClinicalTrials.gov ID
- NCT03241524
- Acronym / sponsor ID
- 28032017
- Keywords
- Pelvic Floor muscles, Physical Therapy, Sexual function evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 12 Mar 2016 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise program for pelvic muscle floor | Experimental | Other: Exercise program for pelvic muscle floorTraining 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Do not continue with the intervention program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program for pelvic muscle floorPelvic 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. | Other | Exercise program for pelvic muscle floor |
Primary outcome
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.
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.
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.
2 secondary outcomes
Pelvic floor muscles performance quantified by PERFECT method
Time frame: 8 weeks
Pelvic floor muscles performance quantified by PERITRON method
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- BackgroundSacomori C, Virtuoso JF, Kruger AP, Cardoso FL. [Pelvic floor muscle strength and sexual function in women]. Fisioterapia e Movimento, 28, 657-665, 2015.
- Results publication: PubMed 23745356Damjanovic 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.
- Derived from this study: PubMed 30572853da 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program for pelvic muscle floor in people with Sexual Dysfunction, Physiological and Sexual Dysfunctions, Psychological, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of female sexual response by Female Sexual Function Inventory (FSFI) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241524, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.