Sexual Function DisturbancesNCT05707429
Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease(Inactive Stage)
An observational study of Sexual Function Disturbances and Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Function Disturbances, Inflammatory Bowel Diseases
- What is being tested?
- The Arabic version of The International Index of Erectile Function (IIEF-5), The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F) and Assessment of depression and anxiety
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Feb 2024
- How long will I take part?
- 3 Months
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Will include 2 groups: IBD patients inactive group and healthy control group. IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital. Healthy control group: will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study. All participants will subject to
Who may be able to join
- 18-50 years old.
- Both sexes
- A stable sexual partner for ≥3 months
- ability to fill in and understand the questionnaire
- sign informed consent and participate voluntarily. For control group: An age-matched control group of healthy men and women, in the same region will also be invited to participate. The controls will eligible if they are 18-50 years of age, have a stable heterosexual relationship for at least 3 months and do not have bowel like IBD or irritable bowel syndrome or psychiatric problems.
Who cannot join
- Those who couldn't understand or fill out the questionnaire themselves and/or those with mental disorders
- Diagnosis of SD before an IBD diagnosis
- SD compounded by other diseases: cardiovascular and cerebrovascular diseases, lung diseases, liver and kidney dysfunction, diabetic neuropathy, other psychiatric disorders (e.g. depression), and neoplastic diseases, etc.
- History or current use of psychotropic drugs or medications have sexual side effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease During Remmsion
Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).
Read the detailed description
Inflammatory Bowel Diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are characterized by a chronically relapsing course (1).
IBD is likely to have a substantial impact on body image, intimacy and sexuality, Because of symptoms like abdominal pain, fatigue, bloating, gas, and diarrhea (2).
Complications may include perianal disease, fistulae and abscesses. Surgery is frequently necessary, sometimes including the placement of a stoma or pouch. Furthermore, mood disorders, mainly depression, are reported to be common in IBD (3) .
Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).
For female IBD patients, SD mainly manifests as decreased sexual desire, orgasm, and sexual arousal disorder, while for men, the most common symptom is erectile dysfunction (ED) (6).
Friedman and Knowles et al. reported that the prevalence of SD in male and female IBD patients ranged from 44% to 53.9% and 40% to 66%, respectively (7).
However, SD in IBD patients still has not attracted widespread attention, and relevant research studies are scarce.
The current study aims to assess sexual functions in patients with inactive IBD and its associated factors with sociodemographic and clinical characteristics.
assessment sexual function among inflammatory bowel disease during disease inactivity
it will evaluate the predictors and impact of SD on quality of life among those patients
- Being tested
- The Arabic version of The International Index of Erectile Function (IIEF-5), The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F), Assessment of depression and anxiety, The Fatigue assessment scale (16), • Quality of life assessment
- Medical subject headings
- Sexual Dysfunctions, Psychological, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Arabic version of The International Index of Erectile Function (IIEF-5)Other
The Arabic version of The International Index of Erectile Function A self-administered questionnaire that assesses 5 dimensions of sexual function over the most recent 4 weeks. It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection. A total score of < 22 is defined as ED .
The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F)Other
was developed by Symonds et al.,(14) which assesses subjects' feelings toward their sexuality (ranging from 0% to 100%, with higher scores indicating higher SQoL). The SQoL M/F was developed as a condition-specific QoL questionnaire to test the relationship between sexual symptoms and other aspects of general health and sexual QoL.
Assessment of depression and anxietyOther
Arabic version of Hamilton depression and anxiety rating scale (15): used to measure the severity of anxiety and depressive symptoms, and is widely used in both clinical and research settings.
The Fatigue assessment scale (16)Other
It is a 10-item self-report scale evaluating symptoms of fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.
• Quality of life assessmentOther
Health related quality of life (HRQoL measure): using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (17), which assesses physical, social, and emotional domains of IBD patients' lives (scores range from 10-70, with higher scores indicating better HRQoL) The SIBDQ reflects relevant clinical changes in both CD and UC.
The Female Sexual Function Index (FSFI)Other
The FSFI includes such parameters as desire, arousal, lubrication, orgasm, satisfaction, and pain. The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study. Receives: Other: The Arabic version of The International Index of Erectile Function (IIEF-5); Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F); Other: Assessment of depression and anxiety; Other: The Fatigue assessment scale (16); Other: • Quality of life assessment; Other: The Female Sexual Function Index (FSFI) | |
| IBD patients inactive group | IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital.
CD patients will be assessed by the Crohn's Disease Activity Index a score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease (9). Receives: Other: The Arabic version of The International Index of Erectile Function (IIEF-5); Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F); Other: Assessment of depression and anxiety; Other: The Fatigue assessment scale (16); Other: • Quality of life assessment; Other: The Female Sexual Function Index (FSFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
inactive IBD &sexual function of both males
using questionnaire IIEF-5 score It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection
- A total score of < 22 is defined as ED . females using FSFI score.
- The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD
Measured: 3 months
Secondary outcomes (1)
Mean scores for quality of life among inactive IBD patients
(using health related quality of life questionnaire)
The SQoL M/F was developed as a condition-specific QoL questionnaire to test the relationship between sexual symptoms and other aspects of general health and sexual QoL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function DisturbancesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa osman taha, Assiut University
- Investigators
- ahmed mahmoud abd ella hassan, MD, Study chair, Assiut university ,andrology departementmostafa Mohammed Hashem, MD, Study director, Assiut Universityahmed abdelfadeel maghrapy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707429
- Sponsor's protocol ID
- assiut IBD
- Status last verified
- Mar 2024
- First submitted
- 14 Jan 2023
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease During Remmsion
- ClinicalTrials.gov ID
- NCT05707429
- Acronym / sponsor ID
- assiut IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 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.
Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).
Detailed description
Inflammatory Bowel Diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are characterized by a chronically relapsing course (1).
IBD is likely to have a substantial impact on body image, intimacy and sexuality, Because of symptoms like abdominal pain, fatigue, bloating, gas, and diarrhea (2).
Complications may include perianal disease, fistulae and abscesses. Surgery is frequently necessary, sometimes including the placement of a stoma or pouch. Furthermore, mood disorders, mainly depression, are reported to be common in IBD (3) .
Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).
For female IBD patients, SD mainly manifests as decreased sexual desire, orgasm, and sexual arousal disorder, while for men, the most common symptom is erectile dysfunction (ED) (6).
Friedman and Knowles et al. reported that the prevalence of SD in male and female IBD patients ranged from 44% to 53.9% and 40% to 66%, respectively (7).
However, SD in IBD patients still has not attracted widespread attention, and relevant research studies are scarce.
The current study aims to assess sexual functions in patients with inactive IBD and its associated factors with sociodemographic and clinical characteristics.
assessment sexual function among inflammatory bowel disease during disease inactivity
it will evaluate the predictors and impact of SD on quality of life among those patients
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Other: The Arabic version of The International Index of Erectile Function (IIEF-5), Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F), Other: Assessment of depression and anxiety, Other: The Fatigue assessment scale (16), Other: • Quality of life assessment, Other: The Female Sexual Function Index (FSFI)will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study. |
| IBD patients inactive group | – | Other: The Arabic version of The International Index of Erectile Function (IIEF-5), Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F), Other: Assessment of depression and anxiety, Other: The Fatigue assessment scale (16), Other: • Quality of life assessment, Other: The Female Sexual Function Index (FSFI)IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital. CD patients will be assessed by the Crohn's Disease Activity Index a score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease (9). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Will include 2 groups: IBD patients inactive group and healthy control group. IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital. Healthy control group: will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study. All participants will subject to
Key inclusion criteria (5 listed)
- 18-50 years old.
- Both sexes
- A stable sexual partner for ≥3 months
- ability to fill in and understand the questionnaire
- sign informed consent and participate voluntarily. For control group: An age-matched control group of healthy men and women, in the same region will also be invited to participate. The controls will eligible if they are 18-50 years of age, have a stable heterosexual relationship for at least 3 months and do not have bowel like IBD or irritable bowel syndrome or psychiatric problems.
Key exclusion criteria (4 listed)
- Those who couldn't understand or fill out the questionnaire themselves and/or those with mental disorders
- Diagnosis of SD before an IBD diagnosis
- SD compounded by other diseases: cardiovascular and cerebrovascular diseases, lung diseases, liver and kidney dysfunction, diabetic neuropathy, other psychiatric disorders (e.g. depression), and neoplastic diseases, etc.
- History or current use of psychotropic drugs or medications have sexual side effects.
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 |
|---|---|---|
| The Arabic version of The International Index of Erectile Function (IIEF-5)The Arabic version of The International Index of Erectile Function A self-administered questionnaire that assesses 5 dimensions of sexual function over the most recent 4 weeks. It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection. A total score of < 22 is defined as ED . | Other | Healthy control group, IBD patients inactive group |
| The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F)was developed by Symonds et al.,(14) which assesses subjects' feelings toward their sexuality (ranging from 0% to 100%, with higher scores indicating higher SQoL). The SQoL M/F was developed as a condition-specific QoL questionnaire to test the relationship between sexual symptoms and other aspects of general health and sexual QoL. | Other | Healthy control group, IBD patients inactive group |
| Assessment of depression and anxietyArabic version of Hamilton depression and anxiety rating scale (15): used to measure the severity of anxiety and depressive symptoms, and is widely used in both clinical and research settings. | Other | Healthy control group, IBD patients inactive group |
| The Fatigue assessment scale (16)It is a 10-item self-report scale evaluating symptoms of fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. | Other | Healthy control group, IBD patients inactive group |
| • Quality of life assessmentHealth related quality of life (HRQoL measure): using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (17), which assesses physical, social, and emotional domains of IBD patients' lives (scores range from 10-70, with higher scores indicating better HRQoL) The SIBDQ reflects relevant clinical changes in both CD and UC. | Other | Healthy control group, IBD patients inactive group |
| The Female Sexual Function Index (FSFI)The FSFI includes such parameters as desire, arousal, lubrication, orgasm, satisfaction, and pain. The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD. | Other | Healthy control group, IBD patients inactive group |
Primary outcome
inactive IBD &sexual function of both males
Time frame: 3 months
using questionnaire IIEF-5 score It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection * A total score of < 22 is defined as ED . females using FSFI score. * The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD
1 secondary outcome
Mean scores for quality of life among inactive IBD patients
Time frame: 3 months
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 19 Mar 2024.
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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.
ahmed mahmoud abd ella hassan, MD study chair
Assiut university ,andrology departement
mostafa Mohammed Hashem, MD study director
Assiut University
ahmed abdelfadeel maghrapy, MD study director
Assiut University
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 Function Disturbances and Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 4 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 19 Mar 2024. 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 Egypt. 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?
inactive IBD &sexual function of both males (time frame: 3 months). 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 19 Mar 2024.