Sexual ActivityFSFACNCT04592848
Female Sexual Function After Cystectomy
An observational study of Sexual Activity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Sexual Activity
- What is being tested?
- Questionnaires
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists in alive female patients aged 18-75 years, who undergone a partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital and able to complete the questionnaires. All patients suffer from urological disorders caused by a non-malignant pathology, and have had surgery after failure of conservative therapies. Among the patients identified from the computerized medical records, 55 suffer from Multiple sclerosis, 29 patients from Spinal Cord Injury, 21 suffer from Suprapontine and pontine lesion or disease, 19 suffer from non-traumatic lesion or disease between caudal brainstem and sacral spinal cord,18 suffer from lesions of the peripheral nervous system, 8 suffer from interstitial cystitis or idiopathic disorders and 1 suffers from a neurodegenerative disease of unknown etiology
Who may be able to join
- Female patients aged from 18 to 75 years
- With Partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital.
- Surgery was performed for urological disorders caused by a non-malignant disease
- Patients currently more than 6 months away from the last urological cystectomy/ urinary diversion/ urinary stoma repair surgery
Who cannot join
- Patients deceased
- Patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement
- Patients unable to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease
Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments.
This surgery has both the objective of preventing urological complications and improving quality of life.
Read more
We know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. Patients are often young and sexually active before the surgery.
Despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients.
Indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer.
Data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. We can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life.
Thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.
- Conditions
- Sexual Activity
- Being tested
- Questionnaires
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Four Questionnaires in French will be sent to participants :
- 1 questionnaire about sexual and urinary symptoms before and after the surgery ;
- 1 validated questionnaire "Female Sexual Function Index" to assess sexual function over the past 4 weeks ;
- 1 validated questionnaire "Body Image Scale" to assess body image during the past week ;
- 1 validated questionnaire "Stoma Quality of Life", only for patients with incontinent urostomy.
If the questionnaires are not returned 15 days after sending, a follow-up phone call will be made by one of the investigators.
The data collection will include both the answers to the questionnaires and the patients' computerized medical data:
- Pathology responsible for the urological disorders and date of onset of the disorders
- Date and Type of surgery performed
- Patient's age at the time of surgery
- Post-operative complications within one month of surgery
| Study group | Role | What they receive |
|---|---|---|
| Population study | Female patients who undergone a cystectomy and/or urinary diversion for a non-malignant disease at "Lyon Sud" Hospital between January 2007 and December 2019. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSFI Total Score in study population
The FSFI Score will be obtained from answers of the validated questionnaire "Female Sexual Function Index", a 19-item self-report measure of female sexual function.
It uses a 5-point Likert scale ranging from 1-5 for each item. It provides scores on overall levels of sexual function and its six components: Desire, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The full scale score is between 2 and 36.
According to literature, total score of 26 or less indicates a risk of sexual dysfunction.
The version used in this study is the French one.
Measured: at least 6 months after the surgery (Cystectomy and/or urinary diversion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start21 Jan 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ActivityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592848
- Sponsor's protocol ID
- 69HCL20_0873
- Acronym
- FSFAC
- Status last verified
- Apr 2022
- First submitted
- 16 Oct 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease
- ClinicalTrials.gov ID
- NCT04592848
- Acronym / sponsor ID
- FSFAC / 69HCL20_0873
- Conditions
- Sexual Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 19 Oct 2020 (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.
Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments.
This surgery has both the objective of preventing urological complications and improving quality of life.
We know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. Patients are often young and sexually active before the surgery.
Despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients.
Indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer.
Data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. We can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life.
Thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population study | – | Other: QuestionnairesFemale patients who undergone a cystectomy and/or urinary diversion for a non-malignant disease at "Lyon Sud" Hospital between January 2007 and December 2019. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists in alive female patients aged 18-75 years, who undergone a partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital and able to complete the questionnaires. All patients suffer from urological disorders caused by a non-malignant pathology, and have had surgery after failure of conservative therapies. Among the patients identified from the computerized medical records, 55 suffer from Multiple sclerosis, 29 patients from Spinal Cord Injury, 21 suffer from Suprapontine and pontine lesion or disease, 19 suffer from non-traumatic lesion or disease between caudal brainstem and sacral spinal cord,18 suffer from lesions of the peripheral nervous system, 8 suffer from interstitial cystitis or idiopathic disorders and 1 suffers from a neurodegenerative disease of unknown etiology
Key inclusion criteria (4 listed)
- Female patients aged from 18 to 75 years
- With Partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital.
- Surgery was performed for urological disorders caused by a non-malignant disease
- Patients currently more than 6 months away from the last urological cystectomy/ urinary diversion/ urinary stoma repair surgery
Key exclusion criteria (3 listed)
- Patients deceased
- Patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement
- Patients unable to complete the questionnaires
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 |
|---|---|---|
| QuestionnairesFour Questionnaires in French will be sent to participants : * 1 questionnaire about sexual and urinary symptoms before and after the surgery ; * 1 validated questionnaire "Female Sexual Function Index" to assess sexual function over the past 4 weeks ; * 1 validated questionnaire "Body Image Scale" to assess body image during the past week ; * 1 validated questionnaire "Stoma Quality of Life", only for patients with incontinent urostomy. If the questionnaires are not returned 15 days after sending, a follow-up phone call will be made by one of the investigators. The data collection will include both the answers to the questionnaires and the patients' computerized medical data: * Pathology responsible for the urological disorders and date of onset of the disorders * Date and Type of surgery performed * Patient's age at the time of surgery * Post-operative complications within one month of surgery | Other | Population study |
Primary outcome
FSFI Total Score in study population
Time frame: at least 6 months after the surgery (Cystectomy and/or urinary diversion)
The FSFI Score will be obtained from answers of the validated questionnaire "Female Sexual Function Index", a 19-item self-report measure of female sexual function. It uses a 5-point Likert scale ranging from 1-5 for each item. It provides scores on overall levels of sexual function and its six components: Desire, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The full scale score is between 2 and 36. According to literature, total score of 26 or less indicates a risk of sexual dysfunction. The version used in this study is the French one.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Activity, run by Hospices Civils de Lyon 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSFI Total Score in study population (time frame: at least 6 months after the surgery (Cystectomy and/or urinary diversion)). 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 29 Apr 2022.