Sexual Health After Endometriosis Surgery (SSACE)

Impact of Deep Endometriosis Surgery on Sexual Health

Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women.

The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life.

The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent.

Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Other: Female Sexual Function Index questionnaire

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).

Exclusion Criteria:

• Minor patient
• No indication for operation or indication of hysterectomy
• Isolated uterine adenomyosis
• Patient opposing her participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Major women operated for deep endometriosis; Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).	Other: Female Sexual Function Index questionnaire; Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consequences of the surgical management of a deep endometriosis on the quality of the sexual life of the patients.	Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).	4 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Mathieu Poilblanc, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): February 9, 2020
• Study Completion (Actual): February 9, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 69HCL18_0656

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No