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

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

      • Antalya, Turkey
        • Recruiting
        • Antalya Tarining and Research Hospital Ethics Commitee
        • Contact:

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

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

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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