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RECRUITING
NCT05728281
NA

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

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2023-06-05

Completion Date

2026-10-05

Last Updated

2025-07-23

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

University Hospital of Angers

Angers, France