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Completed

NCT Number: NCT03176069

Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)

Sexuality is considered one of the pillars of quality of life, an integral part of the personality of each individual. Being a basic human being need, it cannot be separated from other aspects of life. For several centuries and until recently, sexuality was considered the "lower instincts" expression related only to the sexual act. Sex is associated with "reproduction" of the sexual energy. On the other hand, the exercise of sexuality includes various factors such as the building of the sensitivity between individuals like touch, dance, fantasy, look, etc. For a long time feminine sexuality was predominantly focused on procreation and has only recently been considered as an integral part of sexual and reproductive rights of women. Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women, influencing the quality of the couple's relationship. The scientific literature emphasizes the importance of the examination, diagnosis and physical therapy for this dysfunction, but until now there is no quantification or evaluation of the pelvic floor muscles for this group of women, which justifies the realization of this project.

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Key information

About this study

Psychosocial, cultural and relational factors, frequently influenced by a rigid education, have been related to the etiology of sexual difficulties. Women with stable partners who maintain an no consummated pattern of sexual intercourse (vaginismus) reveal a history of sexual life affected by these factors.

Vaginismus is a female sexual dysfunction that affects the quality of sexual and psychosocial lives of women. It may influence both the quality of the couple's relationship and the overall emotional and motivational state of people in their daily activities.

There is a concordance in the scientific literature that physiotherapy is of high importance in the treatment of vaginismus. The scientific literature presents some studies confirming its importance and highlighting the satisfactory results obtained at posttreatment of these dysfunctions.

Considering the impact of vaginismus in the sexual life of couples, as well as the relevance of the development of wide-ranging intervention models in the treatment of this disorder, it is appropriate to conduct this study in order to identify and recognize parameters of muscle tonus of women with and without a diagnosis of vaginismus and also to study the effectiveness of physiotherapy resources applied in the treatment of vaginismus.

Objectives

  • Evaluate and compare the pelvic floor musculature of women with and without a diagnosis of vaginismus, by algometry and perineal electromyographic biofeedback;
  • Evaluate and compare the parameters of muscle tonus of the pelvic floor by perineal electromyographic biofeedback in women with and without a diagnosis of vaginismus;
  • Evaluate the pelvic floor musculature of women diagnosed with vaginismus, through algometry and electromyographic biofeedback, after the physiotherapeutic treatment;
  • Evaluate the quality of sexual life and sexual function of women with and without a diagnosis of vaginismus;
  • Evaluate the quality of sexual life and sexual function of women diagnosed with vaginismus, after physiotherapeutic treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Sexual orientation - heterosexual
  • Be in a stable relationship for at least six months
  • Present vaginismus
  • Did not initiated and/or performed previous vaginismus treatment
  • Elementary school level
  • Be available for weekly attendance at ambulatory

Exclusion criteria

  • Severe psychiatric illness (psychosis) or physical incapacity (previous or current)
  • Vaginismus, whose characteristics suggest the need for surgical treatment
  • Cognitive downgrade
  • Absence of a stable relationship
  • Partner with sexual dysfunction that prevents penetration
  • Presence of genital prolapse

Treatment and study plan

Evaluation and Comparison of women pelvic floor with and without sexual dysfunction

Other

Pelvic floor muscles will also be evaluated by electromyographic biofeedback.

The physiotherapeutic treatment

Other

The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:

  • Kinesiotherapy
  • Manual therapy
  • Electrotherapy (electric electrostimulation, ultrasound)
  • Behavioral therapy

Primary outcomes

  1. Quality sex life

    Time frame: 3 months

    Female Sexual Function Index

  2. Female Sexual Function

    Time frame: 3 months

    Sex Index - Female Version (QS-F)

  3. Verification of female anxiety

    Time frame: 3 months

    Hamilton Anxiety Rating Scale (Ham-A)

  4. Verification of female depression

    Time frame: 3 months

    Beck Depression Inventory (BDI)

  5. Check Muscle Activity

    Time frame: 3 months

    Electromyographic biofeedback

  6. Evaluation of Pain

    Time frame: 3 months

    Functional pain scale

  7. Evaluation of Pain

    Time frame: 3 months

    Algometry

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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