NCT05728281 Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
| NCT ID | NCT05728281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Time Between Hysterectomy and Resumption of Sexual Relations |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2026-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2023-06-05 with a primary completion date of 2026-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT05728281 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Time Between Hysterectomy and Resumption of Sexual Relations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728281 currently recruiting?
Yes, NCT05728281 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Angers to inquire about joining.
Where is the NCT05728281 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT05728281 clinical trial?
NCT05728281 is sponsored by University Hospital, Angers. The trial plans to enroll 142 participants.