Association of Erectile Dysfunction With Neuropathic Pain, Disease Activity, and Functional Status in Male Patients With Axial Spondyloarthritis: A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score
研究概览
简要总结
tudy Description Definitions Use this module to describe the study protocol.
- Required
- § Required if Study Start Date is on or after January 18, 2017 [*] Conditionally required
Brief Summary
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详细描述
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:
- Male AS patients receiving anti-TNF therapy,
- Male AS patients receiving only NSAIDs,
- Healthy male volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Anti-TNF Therapy Group
Male patients with ankylosing spondylitis receiving anti-tumor necrosis factor therapy for at least 3 months.
干预措施: Anti-TNF agents (Drug)
NSAID Group
Male patients with ankylosing spondylitis receiving only nonsteroidal anti-inflammatory drugs for at least 3 months.
干预措施: NSAIDs (Drug)
Healthy Control Group
Age-matched healthy male volunteers without inflammatory rheumatic disease.
干预措施: No Treatment (Healthy Controls) (Other)
结局指标
主要结局
Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score
时间窗: 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.
次要结局
- Neuropathic Pain Assessed by LANSS Score(Baseline)
- Quality of Life Assessed by Ankylosing Spondylitis Quality of Life (ASQoL) Score(baseline)
- Disease Activity Assessed by BASDAI Score(Baseline)
- Functional Status Assessed by BASFI Score(Baseline)
- Spinal Mobility Assessed by BASMI Score(Baseline)
- Prevalence of Sexual Dysfunction Based on IIEF Cutoffs(Baseline)
- Prevalence of Neuropathic Pain Based on LANSS Cutoffs(Baseline)
研究者
Altuğ Güner
Uludag University Faculty of Medicine
Bursa City Hospital