RecruitingNot ApplicableNCT05728281

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


Sponsor

University Hospital, Angers

Enrollment

142 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how sexual function changes over time in women who have had a hysterectomy (uterus removal) for a non-cancerous (benign) reason. Hysterectomy is one of the most common gynecological procedures, yet its long-term impact on sexual health is not fully understood. This study will follow women at multiple time points after surgery and use a validated questionnaire (the FSFI) to assess changes in sexual function, desire, arousal, and satisfaction. You may be eligible if: - You are 18 years of age or older - You are French-speaking - You are sexually active - You are having a total hysterectomy for a benign condition (such as fibroids, adenomyosis, endometriosis, cervical dysplasia, or pelvic floor disorder) - You have signed the informed consent form You may NOT be eligible if: - There are no specific exclusion criteria beyond the inclusion requirements above — all eligible women undergoing the procedure for benign causes are welcome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRecommended 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

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NCT05728281


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