Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

Endometriosis Clinical Trial

— DYSEXTRIOSE  

Official title:

Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402791
• Other study ID #: LOCAL/2011/SD-05
• Secondary ID: 2011-A00564-37
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: March 25, 2015
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score for the SFQ questionnaire	Score for the SFQ questionnaire; varies from 0 to 5.	Day 1	No
Primary	Score for the IIEF questionnaire	Score for the IIEF questionnaire; varies from 0 to 75.	Day 1	No
Secondary	Scores for each sub-domain of the SFQ questionnaire	Scores for each sub-domain of the SFQ questionnaire; varies from 0 to 5.	Day 1	No
Secondary	Scores for each sub-domain of the IIEF questionnaire	Scores for each sub-domain of the IIEF questionnaire; varies from 0 to 30.	Day 1	No
Secondary	Sexual treatment request (yes/no)	Did the patients request treatment/help for sexual problems? yes/no	Day 1	No