NCT02484196

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
5.9 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

June 23, 2015

Last Update Submit

January 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

QuestionnairesBEHAVIORAL

Questionnaires

CouplesWomen

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DyspareuniaEndometriosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 29, 2015

Study Start

June 1, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01