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Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health

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ClinicalTrials.gov Identifier: NCT02484196
Recruitment Status : Unknown
Verified March 2016 by Stefano Angioni, University of Cagliari.
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2015
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari

Brief Summary:
Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.

Condition or disease Intervention/treatment
Dyspareunia Endometriosis Behavioral: Questionnaires

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Couples
Women, with their partners, referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis.
Behavioral: Questionnaires
Women
Women referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis.
Behavioral: Questionnaires



Primary Outcome Measures :
  1. Quality of sexual life [ Time Frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women, and their parteners, affected by endometriosis with dyspareunia, referred to the Obstetrics and Gynecological Department of the University Hospital for the treatment of endometriosis
Criteria

Inclusion Criteria:

  • Women affected by endometriosis with dyspareunia;
  • Women in waiting list for surgery

Exclusion Criteria:

  • Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
  • Psychiatric diseases
  • Refusal or inability to sign the informed consent
  • Pregnancy
  • Previous gynecological surgery
  • End of couple relationship

Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02484196     History of Changes
Other Study ID Numbers: ENDODISP14
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Endometriosis
Dyspareunia
Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders