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临床试验/NCT03176069
NCT03176069已完成不适用

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

Faculdade de Ciências Médicas da Santa Casa de São Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Check Muscle Activity

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group A - women diagnosed with vaginismus

Active Comparator

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

干预措施: The physiotherapeutic treatment (Other)

Group B - women without a diagnosis of vaginismus

Active Comparator

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.

干预措施: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction (Other)

结局指标

主要结局

Check Muscle Activity

时间窗: 3 months

Electromyographic biofeedback

Female Sexual Function

时间窗: 3 months

Sex Index - Female Version (QS-F)

Verification of female depression

时间窗: 3 months

Beck Depression Inventory (BDI)

Verification of female anxiety

时间窗: 3 months

Hamilton Anxiety Rating Scale (Ham-A)

Quality sex life

时间窗: 3 months

Female Sexual Function Index

Evaluation of Pain

时间窗: 3 months

Functional pain scale

次要结局

未报告次要终点

研究者

发起方
Faculdade de Ciências Médicas da Santa Casa de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Profa. Dra. Vera Lúcia dos Santos Alves

Associate Professor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

研究点 (1)

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