Vaginismus Clinical Trial
Official title:
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
Verified date | June 2019 |
Source | Faculdade de Ciências Médicas da Santa Casa de São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 3, 2019 |
Est. primary completion date | June 3, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Santa Casa of Sao Paulo Medical School | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Faculdade de Ciências Médicas da Santa Casa de São Paulo |
Brazil,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality sex life | Female Sexual Function Index | 3 months | |
Primary | Female Sexual Function | Sex Index - Female Version (QS-F) | 3 months | |
Primary | Verification of female anxiety | Hamilton Anxiety Rating Scale (Ham-A) | 3 months | |
Primary | Verification of female depression | Beck Depression Inventory (BDI) | 3 months | |
Primary | Check Muscle Activity | Electromyographic biofeedback | 3 months | |
Primary | Evaluation of Pain | Functional pain scale | 3 months | |
Primary | Evaluation of Pain | Algometry | 3 months |
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