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

Sponsor

University of Cagliari (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02484196

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Phase
Dyspareunia Endometriosis	Behavioral: Questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	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 Questionnaires
Women Women referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis.	Behavioral: Questionnaires Questionnaires

Arm

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

Questionnaires

Women

Women referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis.

Behavioral: Questionnaires

Questionnaires

Outcome Measures

Primary Outcome Measures

Quality of sexual life [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefano Angioni, Associate Professor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT02484196

Other Study ID Numbers:

ENDODISP14

First Posted:

Jun 29, 2015

Last Update Posted:

Feb 2, 2021

Last Verified:

Jan 1, 2021

Additional relevant MeSH terms:

Endometriosis

Dyspareunia

Study Results

No Results Posted as of Feb 2, 2021