Ankylosing SpondylitisNCT04411485
Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Sexual Dysfunction, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety, depression, hormonal deficiency, drug use… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Sexual Dysfunction
- What is being tested?
- Sexual dysfunction
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 15 Jul 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ankylosing spondylitis diagnosed by the rheumatologist
Who may be able to join
- Being diagnosed with AS for individuals with AS,
- No additional disease (comorbid and psychiatric disease, hypothyroidism, hypopituitarism, hypogonadism or hyperprolactinemia)
- Having a partner (relationship status in a monogamous sexual relationship),
- Not smoking and drinking,
- Non-AS partner have not been diagnosed with AS and their partner is AS.
Who cannot join
- Overweight or obesity (BMI <28 kg / m2)
- Having had a pelvic injury, urological or gynecological operation in the last 3 months
- Hypogonadism; penile abnormalities such as hypospadias, congenital curvature or Peyronie's disease with preserved penis stiffness
- Prostatic disorder
- Use of drugs that may affect erectile function (steroids, antihistamines, ß-blockers or SSRIs)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Antalya Tarining and Research Hospital Ethics Commitee
Antalya
Aysel Uysal, MD, +90 242 249 44 00-4217, etik.kurul.07@gmail.com
About this study
Official title: Evaluation of Sexual Satisfaction and Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis
The adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety, depression, hormonal deficiency, drug use, decreased libido and poor body image. Depending on these factors, sexual intercourse and frequency of sexual intercourse may decrease. Sexual dysfunction may be seen in AS due to physical and emotional problems caused by the disease.
Read the detailed description
There are many studies in the literature that determine sexual satisfaction and sexual dysfunction in individuals with AS and compare individuals with AS to healthy individuals . In the light of these studies, the investigators thought that the sexual function of partner of individuals with AS may also be affected negatively. In the literature, no previous study examines the sexual function of partner of individuals with AS. Therefore, the aim was to determine the sexual function of partner of individuals with AS and to compare with healthly adults of the same sex.
- Conditions
- Ankylosing Spondylitis, Sexual Dysfunction
- Being tested
- Sexual dysfunction
- Keywords
- Ankylosing spondylitis, sexual dysfunction
- Medical subject headings
- Spondylitis, Ankylosing, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual dysfunctionOther
Sexual dysfunction will be determined with separate scales for women and men
| Study group | Role | What they receive |
|---|---|---|
| Group of Ankylosing Spondylitis | Patient with ankylosing spondylitis diagnosed by a rheumatologist Receives: Other: Sexual dysfunction | |
| Group of control | Healthy volunteers of the same age and gender as patients Receives: Other: Sexual dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Scale
It is a Likert-type scale that evaluates sexual dysfunction in women consisting of 19 items. The validity and reliability study of FSFI was performed by Rosen et al. (8). The scale consists of six items: desire, arousal, lubrication, orgasm, sexual satisfaction and pain. Each title is scored between 0 or 1 to 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. Rosen et al. (2000) in their study of functional status; The FSFI score was classified as good if> 30, moderate between 23-29, and poor if <23 .
Measured: 1 week
International Erectile Function Form
The questionnaire, which consists of 15 questions in total, determines the participants' erectile function, orgasmic function, sexual desire, sexual satisfaction and overall satisfaction and these 5 different sexual function areas are scored according to the answers received. It is a Likert type scale. As the score increases, it means that each area is good.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start15 Feb 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Ayan, Antalya Training and Research Hospital
- Investigators
- Ayse Ayan, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411485
- Sponsor's protocol ID
- 2016-098
- Status last verified
- Jun 2020
- First submitted
- 28 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is a data to make individual participant data (IPD) available to other researchers.
Publications
Liu YF, Dong H, Chen Z, Wang YU, Tu SH. Impact of ankylosing spondylitis on sexual function: A systematic review and meta-analysis. Exp Ther Med. 2015 Apr;9(4):1501-1507. doi: 10.3892/etm.2015.2239. Epub 2015 Jan 29.
PubMed 25780459
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sexual Satisfaction and Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04411485
- Acronym / sponsor ID
- 2016-098
- Conditions
- Ankylosing Spondylitis, Sexual Dysfunction
- Keywords
- Ankylosing spondylitis, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 2 Jun 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.
The adverse effects of rheumatologic diseases, especially Ankylosing Spondylitis (AS), on sexual functions are known. The causes of sexual dysfunction in rheumatologic diseases are due to factors such as pain, weakness, fatigue, stiffness, functional disability, anxiety, depression, hormonal deficiency, drug use, decreased libido and poor body image. Depending on these factors, sexual intercourse and frequency of sexual intercourse may decrease. Sexual dysfunction may be seen in AS due to physical and emotional problems caused by the disease.
Detailed description
There are many studies in the literature that determine sexual satisfaction and sexual dysfunction in individuals with AS and compare individuals with AS to healthy individuals . In the light of these studies, the investigators thought that the sexual function of partner of individuals with AS may also be affected negatively. In the literature, no previous study examines the sexual function of partner of individuals with AS. Therefore, the aim was to determine the sexual function of partner of individuals with AS and to compare with healthly adults of the same sex.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Ankylosing Spondylitis | – | Other: Sexual dysfunctionPatient with ankylosing spondylitis diagnosed by a rheumatologist |
| Group of control | – | Other: Sexual dysfunctionHealthy volunteers of the same age and gender as patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankylosing spondylitis diagnosed by the rheumatologist
Key inclusion criteria (5 listed)
- Being diagnosed with AS for individuals with AS,
- No additional disease (comorbid and psychiatric disease, hypothyroidism, hypopituitarism, hypogonadism or hyperprolactinemia)
- Having a partner (relationship status in a monogamous sexual relationship),
- Not smoking and drinking,
- Non-AS partner have not been diagnosed with AS and their partner is AS.
Key exclusion criteria (5 listed)
- Overweight or obesity (BMI <28 kg / m2)
- Having had a pelvic injury, urological or gynecological operation in the last 3 months
- Hypogonadism; penile abnormalities such as hypospadias, congenital curvature or Peyronie's disease with preserved penis stiffness
- Prostatic disorder
- Use of drugs that may affect erectile function (steroids, antihistamines, ß-blockers or SSRIs)
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 |
|---|---|---|
| Sexual dysfunctionSexual dysfunction will be determined with separate scales for women and men | Other | Group of Ankylosing Spondylitis, Group of control |
Primary outcome
Female Sexual Function Scale
Time frame: 1 week
It is a Likert-type scale that evaluates sexual dysfunction in women consisting of 19 items. The validity and reliability study of FSFI was performed by Rosen et al. (8). The scale consists of six items: desire, arousal, lubrication, orgasm, sexual satisfaction and pain. Each title is scored between 0 or 1 to 6. The lowest score is two (2) and the highest score is thirty-six (36). A higher score means better function. Rosen et al. (2000) in their study of functional status; The FSFI score was classified as good if> 30, moderate between 23-29, and poor if <23 .
International Erectile Function Form
Time frame: 1 week
The questionnaire, which consists of 15 questions in total, determines the participants' erectile function, orgasmic function, sexual desire, sexual satisfaction and overall satisfaction and these 5 different sexual function areas are scored according to the answers received. It is a Likert type scale. As the score increases, it means that each area is good.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 25780459Liu YF, Dong H, Chen Z, Wang YU, Tu SH. Impact of ankylosing spondylitis on sexual function: A systematic review and meta-analysis. Exp Ther Med. 2015 Apr;9(4):1501-1507. doi: 10.3892/etm.2015.2239. Epub 2015 Jan 29.
- Individual participant dataSharing planned: No. there is a data to make individual participant data (IPD) available to other researchers.
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Ankylosing Spondylitis (AS)
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.
Ayse Ayan, MD principal investigator
Antalya Training and Research Hospital
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 Ankylosing Spondylitis and Sexual Dysfunction, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Ayan, MD (+90 545 960 04 78, drayseayan@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Scale (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411485, which also lists 1 linked publication.
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 4 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.