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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Angers

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Patient ≥ 18 years old,

Francophone,

Sexually active,

Receiving a conservative or non-conservative total hysterectomy for benign pathology*,

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recommended time after hysterectomy

    Other intervention

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Resumption of sexual intercourse recommended 4 weeks after hysterectomyOther 1 intervention
Group B: Resumption of sexual intercourse recommended 8 weeks after hysterectomyOther 1 intervention

Trial outcomes

Primary outcomes

1

The Female Sexual Function Index score

Assessment of the impact of the recommended time between hysterectomy and resumption of sexual intercourse on sexual function using the Female Sexual Function Index score

Time frame
one year

Secondary outcomes

1

Postoperative complications

Describe and compare postoperative complications according to the recommended time between hysterectomy and resumption of sexual intercourse. The postoperative complications studied include dyspareunia, spontaneous pain outside of sexual intercourse, metrorrhagia, infection, and vaginal fundal suture release.

Time frame
one year
2

Follow-up to the recommendation

Describe the follow-up to the recommendation in terms of time to resume sexual intercourse and describe the reasons for not following the recommendation

Time frame
one year

Other outcomes

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