NCT05728281

Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy

Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Time Between Hysterectomy and Resumption of Sexual Relations
• Sexual Function

Interventions

Type	Name	Description
OTHER	Recommended time after hysterectomy	Currently there is no consensus on the optimal time to resume sexual activity. Using a randomization, we will therefore compare two groups: one, whose postoperative instructions will indicate a resumption of sexual activity from 4 weeks after the operation and the other from 8 weeks postoperatively. The primary endpoint is the FSFI® score. The patients will answer the FSFI® questionnaire preoperatively and then at 3 months after surgery.

Timeline

• Start date: 2023-06-05
• Primary completion: 2026-06-05
• Completion: 2026-10-05
• First posted: 2023-02-15
• Last updated: 2025-07-23

Locations

1 site across 1 country: France