Uludag University Faculty of Medicine
Bursa, 16059, Turkey (Türkiye)
NCT Number: NCT07453628
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Observational
Bursa, 16059, Turkey (Türkiye)
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Ongoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care.
Nonsteroidal anti-inflammatory drugs used as standard treatment.
No pharmacological treatment; healthy volunteers.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
The proportion of participants with neuropathic pain will be determined using established LANSS cutoffs and compared among groups.
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