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NCT Number: NCT07453628

Association of Erectile Dysfunction With Neuropathic Pain, Disease Activity, and Functional Status in Male Patients With Axial Spondyloarthritis: A Cross-Sectional Observational Study

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Key information

About this study

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.

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.

Who can participate

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

Treatment and study plan

Anti-TNF agents

Drug

Ongoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care.

NSAIDs

Drug

Nonsteroidal anti-inflammatory drugs used as standard treatment.

No Treatment (Healthy Controls)

Other

No pharmacological treatment; healthy volunteers.

Primary outcomes

  1. Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score

    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.

Secondary outcomes

  1. Neuropathic Pain Assessed by LANSS Score

    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.

  2. Quality of Life Assessed by Ankylosing Spondylitis Quality of Life (ASQoL) Score

    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.

  3. Disease Activity Assessed by BASDAI Score

    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.

  4. Functional Status Assessed by BASFI Score

    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.

  5. Spinal Mobility Assessed by BASMI Score

    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.

  6. Prevalence of Sexual Dysfunction Based on IIEF Cutoffs

    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.

  7. Prevalence of Neuropathic Pain Based on LANSS Cutoffs

    Time frame: Baseline

    The proportion of participants with neuropathic pain will be determined using established LANSS cutoffs and compared among groups.

Sponsors and collaborators

Lead sponsor

Altuğ Güner

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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