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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402791
First received: July 25, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Endometriosis
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Score for the SFQ questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Score for the SFQ questionnaire; varies from 0 to 5.

  • Score for the IIEF questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Score for the IIEF questionnaire; varies from 0 to 75.


Secondary Outcome Measures:
  • Scores for each sub-domain of the SFQ questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Scores for each sub-domain of the SFQ questionnaire; varies from 0 to 5.

  • Scores for each sub-domain of the IIEF questionnaire [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Scores for each sub-domain of the IIEF questionnaire; varies from 0 to 30.

  • Sexual treatment request (yes/no) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Did the patients request treatment/help for sexual problems? yes/no


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402791

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01402791     History of Changes
Other Study ID Numbers: LOCAL/2011/SD-05, 2011-A00564-37
Study First Received: July 25, 2011
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Endometriosis
Sexual Dysfunctions, Psychological
Genital Diseases, Female
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014