Time Between Hysterectomy and Resumption of Sexual RelationsISHYSNCT05728281
Impact of Time on Sexual Function (FSFI® Score) After Hysterectomy
A study testing Recommended time after hysterectomy in people with Time Between Hysterectomy and Resumption of Sexual Relations and Sexual Function, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Time Between Hysterectomy and Resumption of Sexual Relations, Sexual Function
- What is being tested?
- Recommended time after hysterectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2023to 5 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- Menometrorrhagia,
- Fibroids,
- Adenomyosis,
- Endometriosis,
- Pelvic statics disorder,
- Cervical dysplasia,
- Endometrial cancer not requiring lymph node dissection or additional treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers
Pierre-Emmanuel BOUET, MD, PhD, +33241354213, pierreemmanuel.bouet@chu-angers.fr
About this study
Official title: Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study
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.
- Being tested
- Recommended time after hysterectomy
- Keywords
- benign gynaecological disease, hysterectomy, sexual function, FSFI® score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended time after hysterectomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resumption of sexual intercourse recommended 4 weeks after hysterectomy | Other | Not described Receives: Other: Recommended time after hysterectomy |
| Resumption of sexual intercourse recommended 8 weeks after hysterectomy | Other | Not described Receives: Other: Recommended time after hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (2)
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.
Measured: one year
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 Jun 2023
- Primary completion5 Oct 2027 (estimated)
- Study completion5 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Between Hysterectomy and Resumption of Sexual RelationsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728281
- Sponsor's protocol ID
- 2022-A02714-39
- Acronym
- ISHYS
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recommended Time to Resume Sexual Activity After Hysterectomy: Impact on Sexual Function (FSFI® Score) and Complication Rate ISHYS Study
- ClinicalTrials.gov ID
- NCT05728281
- Acronym / sponsor ID
- ISHYS / 2022-A02714-39
- Keywords
- benign gynaecological disease, hysterectomy, sexual function, FSFI® score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Oct 2027 (estimated)
- Study completion
- 5 Oct 2027 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommended time after hysterectomyCurrently 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. | Other | Resumption of sexual intercourse recommended 4 weeks after hysterectomy, Resumption of sexual intercourse recommended 8 weeks after hysterectomy |
Primary outcome
The Female Sexual Function Index score
Time frame: one year
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
2 secondary outcomes
Postoperative complications
Time frame: one year
Follow-up to the recommendation
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommended time after hysterectomy in people with Time Between Hysterectomy and Resumption of Sexual Relations and Sexual Function, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Female Sexual Function Index score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.