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

This study is currently recruiting participants.
Verified June 2017 by Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176069
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
  Purpose
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.

Condition Intervention
Vaginismus Sexual Dysfunctions Muscular Hypertonicity Muscle Tone Poor Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction Other: The physiotherapeutic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)

Resource links provided by NLM:


Further study details as provided by Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • Quality sex life [ Time Frame: 3 months ]
    Female Sexual Function Index

  • Female Sexual Function [ Time Frame: 3 months ]
    Sex Index - Female Version (QS-F)

  • Verification of female anxiety [ Time Frame: 3 months ]
    Hamilton Anxiety Rating Scale (Ham-A)

  • Verification of female depression [ Time Frame: 3 months ]
    Beck Depression Inventory (BDI)

  • Check Muscle Activity [ Time Frame: 3 months ]
    Electromyographic biofeedback

  • Evaluation of Pain [ Time Frame: 3 months ]
    Functional pain scale

  • Evaluation of Pain [ Time Frame: 3 months ]
    Algometry


Estimated Enrollment: 40
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A - women diagnosed with vaginismus

All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The ultrasound imaging requested at the ambulatorial routine will be performed by a skilled physician and accompanied by the project author. All images will be recorded and digitally stored and will later be measured and treated statistically. The patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification of the musculature shape and mobility.

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

Other: The physiotherapeutic treatment

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
Active Comparator: Group B - women without a diagnosis of vaginismus
All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The ultrasound imaging requested at the ambulatorial routine will be performed by a skilled physician and accompanied by the project author. All images will be recorded and digitally stored and will later be measured and treated statistically. The patient will be lying in a supine position (belly up), with the pelvis in a neutral position, back at 45º and feet supported in stirrups, for the verification of the musculature shape and mobility.
Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction
Pelvic floor muscles will also be evaluated by electromyographic biofeedback.

Detailed Description:

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

  1. Evaluate and compare the pelvic floor musculature of women with and without a diagnosis of vaginismus, by ultrasonographic image and perineal electromyographic biofeedback;
  2. 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;
  3. Evaluate the pelvic floor musculature of women diagnosed with vaginismus, through sonographic imaging and electromyographic biofeedback, after the physiotherapeutic treatment;
  4. Evaluate the quality of sexual life and sexual function of women with and without a diagnosis of vaginismus;
  5. Evaluate the quality of sexual life and sexual function of women diagnosed with vaginismus, after physiotherapeutic treatment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176069


Contacts
Contact: Vera Lúcia dos Santos Alves, PhD +55 11 999707013 fisioterapiasc@uol.com.br
Contact: Carla Maria de Abreu Pereira, Master +55 11 995778100 fisiocarlapereira@gmail.com

Locations
Brazil
Santa Casa of Sao Paulo Medical School Recruiting
Sao Paulo, SP, Brazil
Contact: Vera Lúcia dos Santos Alves, PhD    +55 11 999707013    fisioterapiasc@uol.com.br   
Contact: Carla Maria de Abreu Pereira, Master    +55 11 995778100    fisiocarlapereira@gmail.com   
Principal Investigator: Vera Lúcia dos Santos Alves, PhD         
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
  More Information

Publications:

Responsible Party: Profa. Dra. Vera Lúcia dos Santos Alves, Associate Professor, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03176069     History of Changes
Other Study ID Numbers: 51995515.4.0000.5479
First Submitted: May 12, 2016
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Vaginismus
Muscle Tone
Sexual dysfunctions

Additional relevant MeSH terms:
Vaginismus
Muscle Hypertonia
Muscle Hypotonia
Sexual Dysfunction, Physiological
Genital Diseases, Female
Vaginal Diseases
Sexual Dysfunctions, Psychological
Mental Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms