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NCT Number: NCT05728281

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Angers

Angers, France

Location status: Recruiting

Location contact

Pierre-Emmanuel BOUET, MD, PhD

CONTACT

[email protected]

+33241354213

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recommended time after hysterectomy

Other

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.

Primary outcomes

  1. 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

  1. Postoperative complications

    Time frame: one year

    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.

  2. Follow-up to the recommendation

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: ISHYS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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