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

October 3, 2019 updated by: Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 algometry 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 algometry 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Santa Casa of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A - women diagnosed with vaginismus

All patients will be submitted to anamnesis, physical examination, examination of the pelvic floor. The algometry will be performed with 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 the perineal pain threshold.

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 algometry will be performed with 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 the perineal pain threshold.
Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction
Pelvic floor muscles will also be evaluated by electromyographic biofeedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality sex life
Time Frame: 3 months
Female Sexual Function Index
3 months
Female Sexual Function
Time Frame: 3 months
Sex Index - Female Version (QS-F)
3 months
Verification of female anxiety
Time Frame: 3 months
Hamilton Anxiety Rating Scale (Ham-A)
3 months
Verification of female depression
Time Frame: 3 months
Beck Depression Inventory (BDI)
3 months
Check Muscle Activity
Time Frame: 3 months
Electromyographic biofeedback
3 months
Evaluation of Pain
Time Frame: 3 months
Functional pain scale
3 months
Evaluation of Pain
Time Frame: 3 months
Algometry
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

June 3, 2019

Study Completion (Actual)

June 3, 2019

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51995515.4.0000.5479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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