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

Primary Purpose

Vaginismus, Sexual Dysfunctions, Muscular Hypertonicity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Evaluation and Comparison of women pelvic floor with and without sexual dysfunction
The physiotherapeutic treatment
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaginismus focused on measuring Vaginismus, Muscle Tone, Sexual dysfunctions

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Santa Casa of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A - women diagnosed with vaginismus

Group B - women without a diagnosis of vaginismus

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
October 3, 2019
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03176069
Brief Title
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
Official Title
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginismus, Sexual Dysfunctions, Muscular Hypertonicity, Muscle Tone Poor
Keywords
Vaginismus, Muscle Tone, Sexual dysfunctions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - women diagnosed with vaginismus
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B - women without a diagnosis of vaginismus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluation and Comparison of women pelvic floor with and without sexual dysfunction
Intervention Description
Pelvic floor muscles will also be evaluated by electromyographic biofeedback.
Intervention Type
Other
Intervention Name(s)
The physiotherapeutic treatment
Intervention Description
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 Outcome Measure Information:
Title
Quality sex life
Description
Female Sexual Function Index
Time Frame
3 months
Title
Female Sexual Function
Description
Sex Index - Female Version (QS-F)
Time Frame
3 months
Title
Verification of female anxiety
Description
Hamilton Anxiety Rating Scale (Ham-A)
Time Frame
3 months
Title
Verification of female depression
Description
Beck Depression Inventory (BDI)
Time Frame
3 months
Title
Check Muscle Activity
Description
Electromyographic biofeedback
Time Frame
3 months
Title
Evaluation of Pain
Description
Functional pain scale
Time Frame
3 months
Title
Evaluation of Pain
Description
Algometry
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Santa Casa of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)

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