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Clinical Trials/NCT05728281
NCT05728281RecruitingNot Applicable

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

University Hospital, Angers1 site in 1 country142 target enrollmentStarted: June 5, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
142
Locations
1
Primary Endpoint
The Female Sexual Function Index score

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patient ≥ 18 years old,
  • •Francophone,
  • •Sexually active,
  • •Receiving a conservative or non-conservative total hysterectomy for benign pathology*,
  • •Having signed a consent form. All surgical approaches are considered, laparoscopic approach with laparoscopic or vaginal closure, vaginal approach and laparotomy.
  • •*The indications for the procedure selected for this study include:
  • •Menometrorrhagia,
  • •Fibroids,
  • •Adenomyosis,
  • •Endometriosis,
  • •Pelvic statics disorder,
  • •Cervical dysplasia,
  • •Endometrial cancer not requiring lymph node dissection or additional treatment.

Exclusion Criteria

  • Not provided

Arms & Interventions

Resumption of sexual intercourse recommended 4 weeks after hysterectomy

Other

Intervention: Recommended time after hysterectomy (Other)

Resumption of sexual intercourse recommended 8 weeks after hysterectomy

Other

Intervention: Recommended time after hysterectomy (Other)

Outcomes

Primary Outcomes

The Female Sexual Function Index score

Time Frame: one year

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

Secondary Outcomes

  • Follow-up to the recommendation(one year)
  • Postoperative complications(one year)

Investigators

Sponsor
University Hospital, Angers
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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