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: October 9, 2014
Last verified: October 2014

July 25, 2011
October 9, 2014
January 2011
December 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01402791 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Endometriosis
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.
The study population
All patients included according to state inclusion and exclusion criteria.
Intervention: Other: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01402791
LOCAL/2011/SD-05, 2011-A00564-37
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP