Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Evaluation of Sexual Satisfaction and Sexual Dysfunction in Partner of Patients With Ankylosing Spondylitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411485
• Other study ID #: 2016-098
• Status: Recruiting
• Start date: February 15, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: June 2020
• Source: Antalya Training and Research Hospital
• Contact: Ayse Ayan, MD
• Phone: +90 545 960 04 78
• Email: drayseayan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 15, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Sexual Dysfunction
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Sexual dysfunction
Sexual dysfunction will be determined with separate scales for women and men

Locations

Country	Name	City	State
Turkey	Antalya Tarining and Research Hospital Ethics Commitee	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Epub 2015 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	1 week
Primary	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.	1 week