Ankylosing Spondylitis, Sexual Dysfunction
Conditions
Keywords
Anti-TNF Therapy Tumor Necrosis Factor Inhibitors Erectile Dysfunction Quality of Life BASDAI IIEF LANSS NSAIDs Observational Study
Brief summary
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Detailed description
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease primarily affecting the axial skeleton and leading to progressive spinal stiffness, chronic pain, and functional impairment. The disease commonly affects young adults and may significantly impair physical, psychological, and social well-being. Sexual dysfunction is increasingly recognized as an important yet underreported issue in patients with rheumatic diseases. Chronic pain, fatigue, reduced mobility, depression, altered body image, and systemic inflammation may all contribute to impaired sexual function in AS. In addition, neuropathic pain mechanisms may coexist with inflammatory pain and further affect quality of life and sexual performance. Anti-tumor necrosis factor (anti-TNF) agents are effective in reducing disease activity and improving functional status and quality of life in AS. While improvement in physical symptoms may theoretically enhance sexual function, current evidence regarding the impact of anti-TNF therapy on sexual dysfunction remains limited and inconsistent. This prospective observational study aims to compare sexual function, neuropathic pain, quality of life, and disease activity among three groups: 1. Male AS patients receiving anti-TNF therapy, 2. Male AS patients receiving only NSAIDs, 3. Healthy male volunteers. Sexual function will be assessed using the International Index of Erectile Function (IIEF). Neuropathic pain will be evaluated using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS). Disease activity and functional status will be measured using BASDAI, BASFI, and BASMI indices. Quality of life will be assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. No experimental intervention will be performed, and no changes in ongoing treatments will occur during the study. The primary objective is to determine whether treatment modality and neuropathic pain are associated with sexual dysfunction in male patients with ankylosing spondylitis.
Interventions
DRUGAnti-TNF agents
Ongoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care.
DRUGNSAIDs
Nonsteroidal anti-inflammatory drugs used as standard treatment.
OTHERNo Treatment (Healthy Controls)
No pharmacological treatment; healthy volunteers.
Sponsors
Altuğ Güner
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
Male participants aged 18 years or older Diagnosis of ankylosing spondylitis according to accepted classification criteria (for patient groups) Receiving anti-TNF therapy or NSAIDs for at least 3 months (for patient groups) Ability to understand and complete study questionnaires Provided written informed consent For healthy control group: Male volunteers aged 18 years or older No history of inflammatory rheumatic disease
Exclusion criteria
Age under 18 years Use of anti-TNF therapy or NSAIDs for less than 3 months History of neurological disorders affecting sexual function Known severe psychiatric illness Use of medications known to significantly affect sexual function (e.g., antidepressants, antipsychotics) Refusal to participate or incomplete questionnaire data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score | baseline | Sexual function will be evaluated using the International Index of Erectile Function (IIEF). The total score ranges from 5 to 75, with lower scores indicating more severe erectile dysfunction. Scores will be compared among anti-TNF users, NSAID users, and healthy controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Assessed by LANSS Score | Baseline | Neuropathic pain will be assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS). Scores will be compared among the three groups and evaluated for associations with sexual function measures. |
| Quality of Life Assessed by Ankylosing Spondylitis Quality of Life (ASQoL) Score | baseline | Quality of life will be measured using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Scores will be compared across groups and analyzed in relation to sexual function and neuropathic pain. |
| Disease Activity Assessed by BASDAI Score | Baseline | Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). BASDAI scores will be compared among groups and evaluated for associations with sexual function and neuropathic pain. |
| Functional Status Assessed by BASFI Score | Baseline | Functional status will be assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI). BASFI scores will be compared across groups and analyzed in relation to sexual function and quality of life. |
| Spinal Mobility Assessed by BASMI Score | Baseline | Spinal mobility will be evaluated using the Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI scores will be compared among groups and assessed for relationships with sexual function outcomes. |
| Prevalence of Sexual Dysfunction Based on IIEF Cutoffs | Baseline | The proportion of participants meeting criteria for erectile dysfunction will be determined using standard International Index of Erectile Function (IIEF) cutoffs and compared among groups. |
| Prevalence of Neuropathic Pain Based on LANSS Cutoffs | Baseline | The proportion of participants with neuropathic pain will be determined using established LANSS cutoffs and compared among groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed