ISHYS: Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Resumption of sexual intercourse recommended 4 weeks after hysterectomy
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Other: Recommended 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.
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| Other: Resumption of sexual intercourse recommended 8 weeks after hysterectomy
|
Other: Recommended 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.
|
Outcome Measures
Primary Outcome Measures
- The FSFI® score [one year]
Assessment of the impact of the recommended time between hysterectomy and resumption of sexual intercourse on sexual function using the FSFI® score
Secondary Outcome Measures
- Postoperative complications [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.
- Follow-up to the recommendation [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient ≥ 18 years old,
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Francophone,
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Sexually active,
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Receiving a conservative or non-conservative total hysterectomy for benign pathology*,
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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:
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Menometrorrhagia,
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Fibroids,
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Adenomyosis,
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Endometriosis,
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Pelvic statics disorder,
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Cervical dysplasia,
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Endometrial cancer not requiring lymph node dissection or additional treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Angers
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-A02714-39