Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05728281

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

Led by University Hospital, Angers · Updated on 2025-07-23

142

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years or older
  • French-speaking
  • Sexually active
  • Scheduled for a total hysterectomy for benign conditions including menometrorrhagia, fibroids, adenomyosis, endometriosis, pelvic statics disorder, cervical dysplasia, or certain endometrial cancers
  • Signed informed consent
  • All surgical approaches considered: laparoscopic, vaginal, or abdominal hysterectomy
Not Eligible

You will not qualify if you...

  • Illiteracy
  • Cognitive disorders
  • No social security coverage
  • Judicial or administrative deprivation of liberty
  • Ongoing psychiatric care
  • Under legal protection
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Angers

Angers, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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