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

Sexual Function Clinical Trial

— ISHYS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728281
• Other study ID #: 2022-A02714-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Function

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The FSFI® score	Assessment of the impact of the recommended time between hysterectomy and resumption of sexual intercourse on sexual function using the FSFI® score	one year
Secondary	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.	one year
Secondary	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	one year