NCT03241524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

March 29, 2017

Last Update Submit

August 2, 2017

Conditions

Keywords

Pelvic Floor musclesPhysical TherapySexual function evaluation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    8 weeks

Secondary Outcomes (2)

  • Pelvic floor muscles performance quantified by PERFECT method

    8 weeks

  • Pelvic floor muscles performance quantified by PERITRON method

    8 weeks

Study Arms (1)

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.

Other: Exercise program for pelvic muscle floor

Interventions

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.

Exercise program for pelvic muscle floor

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Do not continue with the intervention program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Physical Therapy

João Pessoa, Paraíba, 58038-10, Brazil

Location

Related Publications (3)

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

    BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMotor Activity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate student

Study Record Dates

First Submitted

March 29, 2017

First Posted

August 7, 2017

Study Start

March 12, 2016

Primary Completion

June 20, 2016

Study Completion

September 12, 2016

Last Updated

August 7, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations