How the timing of resuming sex after a hysterectomy affects sexual function
Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study
NA · University Hospital, Angers · NCT05728281
This study will test whether advising women to wait a shorter or longer time before resuming sex after a hysterectomy changes their sexual function, measured by the FSFI score, in sexually active adult women treated for benign gynecologic conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Angers (other gov) |
| Locations | 1 site (Angers) |
| Trial ID | NCT05728281 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, prospective superiority trial at the University Hospital of Angers enrolling sexually active adult Francophone women undergoing total hysterectomy for benign indications (some selected early endometrial cancers are allowed). Participants are randomized to two groups that receive different recommended waiting times before resuming sexual relations and complete pre- and post-operative questionnaires including the FSFI® instrument. The primary outcome is change in FSFI score; secondary outcomes include comparison of post-operative complications between groups, adherence to the recommendation, and reasons for not following the recommendation. All surgical approaches (laparoscopy, vaginal, laparotomy) and both conservative and non-conservative procedures are permitted.
Who should consider this trial
Good fit: Adult (≥18) Francophone, sexually active women who consent and are scheduled for a total hysterectomy for benign gynecologic conditions (or selected early endometrial cancer not requiring lymph node dissection).
Not a fit: People who are not sexually active, under 18, non‑Francophone, or those requiring extensive cancer treatment or lymph node dissection are unlikely to benefit from this study's guidance.
Why it matters
Potential benefit: If successful, the study could give clear guidance on when to safely resume sexual activity after hysterectomy to help improve sexual function and reduce uncertainty for patients.
How similar studies have performed: This is a relatively novel question with little prior randomized evidence on optimal timing for resuming sexual activity after hysterectomy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Angers
- University Hospital of Angers — Angers, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function, benign gynaecological disease, hysterectomy, sexual function, FSFI® score