Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples (DYSEXTRIOSE)

March 25, 2015 updated by: Centre Hospitalier Universitaire de Nīmes
The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Couples for whom the women have been surgically treated for deep endometriosis at the Nîmes University Hospital

Description

Inclusion Criteria:

  • The patient (and her partner) must have given his/her informed and signed consent
  • The patient (and her partner) must be insured or beneficiary of a health insurance plan
  • Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study

Exclusion Criteria:

  • The patient (or her partner) is participating in another study
  • The patient (or her partner) is in an exclusion period determined by a previous study
  • The patient (or her partner) is under judicial protection, under tutorship or curatorship
  • The patient (or her partner) refuses to sign the consent
  • It is impossible to correctly inform the patient (or her partner)
  • The patient is pregnant
  • The patient is breastfeeding
  • The patient was surgically treated for endometriosis, but was single.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The study population
All patients included according to state inclusion and exclusion criteria.
Other: Questionnaires
All included couples (women and their partners) are required to fill out several questionnaires: 1. Questionnaire for women; 2. Self-questionnaire for women; 3. SFQ for women; 4. Questionnaire for men; 5. Self-questionnaire for men; 6. IIEF for men.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score for the SFQ questionnaire
Time Frame: Day 1
Score for the SFQ questionnaire; varies from 0 to 5.
Day 1
Score for the IIEF questionnaire
Time Frame: Day 1
Score for the IIEF questionnaire; varies from 0 to 75.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores for each sub-domain of the SFQ questionnaire
Time Frame: Day 1
Scores for each sub-domain of the SFQ questionnaire; varies from 0 to 5.
Day 1
Scores for each sub-domain of the IIEF questionnaire
Time Frame: Day 1
Scores for each sub-domain of the IIEF questionnaire; varies from 0 to 30.
Day 1
Sexual treatment request (yes/no)
Time Frame: Day 1
Did the patients request treatment/help for sexual problems? yes/no
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2011/SD-05
  • 2011-A00564-37 (Other Identifier: RCB number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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