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

NCT05728281 | Recruiting

• 1 other identifier: 2022-A02714-39
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Time Between Hysterectomy and Resumption of Sexual Relations; Sexual Function

Keywords

benign gynaecological disease; hysterectomy; sexual function; FSFI® score

Outcome Measures

Primary Outcomes (1)

• The Female Sexual Function Index score

  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

  one year

Secondary Outcomes (2)

• Postoperative complications

  one year

• Follow-up to the recommendation

  one year

Study Arms (2)

Resumption of sexual intercourse recommended 4 weeks after hysterectomy

OTHER

Other: Recommended time after hysterectomy

Resumption of sexual intercourse recommended 8 weeks after hysterectomy

OTHER

Other: Recommended time after hysterectomy

Interventions

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.

Resumption of sexual intercourse recommended 4 weeks after hysterectomy; Resumption of sexual intercourse recommended 8 weeks after hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital of Angers

Angers, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: June 5, 2023
• Primary Completion: June 5, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

FR (1)