NCT04411485

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

May 28, 2020

Last Update Submit

June 2, 2020

Conditions

Ankylosing SpondylitisSexual Dysfunction

Keywords

Ankylosing spondylitissexual dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group of Ankylosing Spondylitis

Patient with ankylosing spondylitis diagnosed by a rheumatologist

Other: Sexual dysfunction

Group of control

Healthy volunteers of the same age and gender as patients

Other: Sexual dysfunction

Interventions

Sexual dysfunctionOTHER

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

Group of Ankylosing SpondylitisGroup of control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ankylosing spondylitis diagnosed by the rheumatologist

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Tarining and Research Hospital Ethics Commitee

Antalya, Turkey (Türkiye)

RECRUITING

Related 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. doi: 10.3892/etm.2015.2239. Epub 2015 Jan 29.

    PMID: 25780459RESULT

MeSH Terms

Conditions

Spondylitis, AnkylosingSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisGenital DiseasesUrogenital Diseases

Study Officials

  • Ayse Ayan, MD

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Ayan, MD

CONTACT

+90 545 960 04 78drayseayan@yahoo.com.tr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

February 15, 2018

Primary Completion

June 30, 2020

Study Completion

July 15, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

there is a data to make individual participant data (IPD) available to other researchers.

Locations

TU(1)