Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

NCT01402791 | Completed

• 2 other identifiers: LOCAL/2011/SD-052011-A00564-37
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• Score for the SFQ questionnaire

  Score for the SFQ questionnaire; varies from 0 to 5.

  Day 1

• Score for the IIEF questionnaire

  Score for the IIEF questionnaire; varies from 0 to 75.

  Day 1

Secondary Outcomes (3)

• Scores for each sub-domain of the SFQ questionnaire

  Day 1

• Scores for each sub-domain of the IIEF questionnaire

  Day 1

• Sexual treatment request (yes/no)

  Day 1

Study Arms (1)

The study population

All patients included according to state inclusion and exclusion criteria.

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• The patient (or her partner) is participating in another 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stéphane Droupy, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

FR (1)