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
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 April 22, 2014