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

NCT03176069 | Completed DMC

• 1 other identifier: 51995515.4.0000.5479
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginismus; Sexual Dysfunctions; Muscular Hypertonicity; Muscle Tone Poor

Keywords

Vaginismus; Muscle Tone; Sexual dysfunctions

Outcome Measures

Primary Outcomes (7)

• Quality sex life

  Female Sexual Function Index

  3 months

• Female Sexual Function

  Sex Index - Female Version (QS-F)

  3 months

• Verification of female anxiety

  Hamilton Anxiety Rating Scale (Ham-A)

  3 months

• Verification of female depression

  Beck Depression Inventory (BDI)

  3 months

• Check Muscle Activity

  Electromyographic biofeedback

  3 months

• Evaluation of Pain

  Functional pain scale

  3 months

• Evaluation of Pain

  Algometry

  3 months

Study Arms (2)

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

Other: The physiotherapeutic treatment

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.

Other: Evaluation and Comparison of women pelvic floor with and without sexual dysfunction

Interventions

Evaluation and Comparison of women pelvic floor with and without sexual dysfunction OTHER

Pelvic floor muscles will also be evaluated by electromyographic biofeedback.

Group B - women without a diagnosis of vaginismus

The physiotherapeutic treatment OTHER

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 A - women diagnosed with vaginismus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Santa Casa of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Location

Related Publications (23)

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  PMID: 25648245 BACKGROUND

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  PMID: 16020150 BACKGROUND

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  PMID: 8579326 BACKGROUND

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  PMID: 25855126 BACKGROUND

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  PMID: 16967145 BACKGROUND

• Engman M, Wijma K, Wijma B. Long-term coital behaviour in women treated with cognitive behaviour therapy for superficial coital pain and vaginismus. Cogn Behav Ther. 2010;39(3):193-202. doi: 10.1080/16506070903571014.

  PMID: 20390584 BACKGROUND

• Kingsberg S, Althof SE. Evaluation and treatment of female sexual disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20 Suppl 1:S33-43. doi: 10.1007/s00192-009-0833-x.

  PMID: 19440781 BACKGROUND

• Lewis RW, Fugl-Meyer KS, Corona G, Hayes RD, Laumann EO, Moreira ED Jr, Rellini AH, Segraves T. Definitions/epidemiology/risk factors for sexual dysfunction. J Sex Med. 2010 Apr;7(4 Pt 2):1598-607. doi: 10.1111/j.1743-6109.2010.01778.x.

  PMID: 20388160 BACKGROUND

• Melnik T, Hawton K, McGuire H. Interventions for vaginismus. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD001760. doi: 10.1002/14651858.CD001760.pub2.

  PMID: 23235583 BACKGROUND

• Pereira VM, Arias-Carrion O, Machado S, Nardi AE, Silva AC. Sex therapy for female sexual dysfunction. Int Arch Med. 2013 Sep 26;6(1):37. doi: 10.1186/1755-7682-6-37.

  PMID: 24066697 BACKGROUND

• Reissing ED, Binik YM, Khalife S, Cohen D, Amsel R. Vaginal spasm, pain, and behavior: an empirical investigation of the diagnosis of vaginismus. Arch Sex Behav. 2004 Feb;33(1):5-17. doi: 10.1023/B:ASEB.0000007458.32852.c8.

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• Reissing ED. Consultation and treatment history and causal attributions in an online sample of women with lifelong and acquired vaginismus. J Sex Med. 2012 Jan;9(1):251-8. doi: 10.1111/j.1743-6109.2011.02534.x. Epub 2011 Oct 24.

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• Seo JT, Choe JH, Lee WS, Kim KH. Efficacy of functional electrical stimulation-biofeedback with sexual cognitive-behavioral therapy as treatment of vaginismus. Urology. 2005 Jul;66(1):77-81. doi: 10.1016/j.urology.2005.01.025.

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• Sirakov M. [Vaginismus and our experience in treating this sexual problem]. Akush Ginekol (Sofiia). 2013;52(1):61-6. Bulgarian.

  PMID: 23805463 BACKGROUND

MeSH Terms

Conditions

Vaginismus; Muscle Hypertonia; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 5, 2017
• Study Start: February 1, 2017
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)