- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411485
Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis
June 2, 2020 updated by: Ayse Ayan, Antalya Training and Research Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Antalya, Turkey
- Recruiting
- Antalya Tarining and Research Hospital Ethics Commitee
-
Contact:
- Aysel Uysal, MD
- Phone Number: +90 242 249 44 00-4217
- Email: etik.kurul.07@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with ankylosing spondylitis diagnosed by the rheumatologist
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group of Ankylosing Spondylitis
Patient with ankylosing spondylitis diagnosed by a rheumatologist
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Sexual dysfunction will be determined with separate scales for women and men
|
|
Group of control
Healthy volunteers of the same age and gender as patients
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Sexual dysfunction will be determined with separate scales for women and men
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
1 week
|
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ayse Ayan, MD, Antalya Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2018
Primary Completion (ANTICIPATED)
June 30, 2020
Study Completion (ANTICIPATED)
July 15, 2020
Study Registration Dates
First Submitted
May 28, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (ACTUAL)
June 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
there is a data to make individual participant data (IPD) available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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