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

Study acronym: ISHYS
StatusRecruiting
PhaseNot applicable
Started2023-06-05
View on ClinicalTrials.gov ↗

Amendment history

2026-06-25
minor
Study Status v3
Primary completion date2026-06-05→2027-10-05
Completion date2026-10-05→2027-10-05
2025-07-18
minor
Study Status, Outcome Measures, IPDSharing v2
Primary endpoints1 entry, revised
The FSFI®Female Sexual Function Index score
2025-07-15
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-02→2026-06-05
Completion date2024-06→2026-10-05
Start dateestimated 2023-02→confirmed 2023-06-05
2023-02-04
minor
Original filing
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.
Trial Details
NCT Number NCT05728281
Lead Sponsor University Hospital, Angers
Conditions Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function
Enrollment 142 participants
Start Date 2023-06-05
Primary Completion 2027-10-05 (estimated)
Study Completion 2027-10-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-26