Clinical trial NCT05728281: Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
Official title: Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time Between Hysterectomy and Resumption of Sexual Relations
Sexual Function
Keywords: benign gynaecological disease
hysterectomy
sexual function
FSFI® score
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-02-15
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In France, more than 62 000 hysterectomies are performed each year. Female sexual function is the result of multiple psychological, social and physiological factors. There is no information in the current literature about the optimum time between the surgery and the sexual relation resumption. The primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using FSFI® score. Secondaries outcomes are: to describe and compare post-operative complications in the two groups of the study, to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed. This study is based on 4 questionnaires: FSFI® pre-operative and post-operative, pre-operative questionnaire and post-operative questionnaire. This is a monocentric, comparative, of superiority, randomised and prospective study. Patients are randomised into two groups: sexual relation resumption advised 4 weeks after surgery, or 8 weeks. The inclusion criteria are more than 18 years, francophone, in sexual activity, scheduled for a total hysterectomy for benign indication (menometrorrhagia, fibroma, adenomyosis, endometriosis, pelvic floor disorders, low-grade endometrial cancer), considering vaginal, laparoscopic and abdominal approach, and a written consent. Non-inclusion criteria are illiteracy, cognitive disorders, without social security, deprived liberty by judicial or administrative decision, psychiatric care, patient with legal protection, patient incapable of giving consent. If our conclusions confirmed our hypothesis, it can improve clinical practices by providing additional informations for surgeon and patient, to undergo this surgery as serenely as possible.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old,
* Francophone,
* Sexually active,
* Receiving a conservative or non-conservative total hysterectomy for benign pathology\*,
* Having signed a consent form. All surgical approaches are considered, laparoscopic approach with laparoscopic or vaginal closure, vaginal approach and laparotomy.

  \*The indications for the procedure selected for this study include:
* Menometrorrhagia,
* Fibroids,
* Adenomyosis,
* Endometriosis,
* Pelvic statics disorder,
* Cervical dysplasia,
* Endometrial cancer not requiring lymph node dissection or additional treatment.

Primary outcomes:
measure: The FSFI® score
timeFrame: one year
Secondary outcomes:
measure: Postoperative complications
timeFrame: one year
measure: Follow-up to the recommendation
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References: