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

Not Applicable

Completed

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

• Registration Number: NCT03176069
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

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

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 Timeline

• Study First Submitted: 2016-05-12
• Study Start: 2017-02-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Status Verified: 2019-06
• Primary Completion: 2019-06-03
• Study Completion: 2019-06-03
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - women diagnosed with vaginismus	The physiotherapeutic treatment	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
Group B - women without a diagnosis of vaginismus	Evaluation and Comparison of women pelvic floor with and without sexual dysfunction	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Santa Casa of Sao Paulo Medical School; 🇧🇷 Sao Paulo, SP, Brazil