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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Brief Summary

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Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Ankylosing Spondylitis
• Intervention / Treatment: Drug: Anti-TNF agents; Drug: NSAIDs; Other: No Treatment (Healthy Controls)

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Faculty Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of male patients with ankylosing spondylitis followed at a tertiary university hospital outpatient clinic and age-matched healthy male volunteers. Patients are grouped according to ongoing treatment (anti-TNF therapy or NSAIDs). Healthy controls are recruited from hospital staff relatives. All participants are adults able to provide informed consent and complete validated questionnaires.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anti-TNF Therapy Group; Male patients with ankylosing spondylitis receiving anti-tumor necrosis factor therapy for at least 3 months.	Drug: Anti-TNF agents; Ongoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care.
NSAID Group; Male patients with ankylosing spondylitis receiving only nonsteroidal anti-inflammatory drugs for at least 3 months.	Drug: NSAIDs; Nonsteroidal anti-inflammatory drugs used as standard treatment.
Healthy Control Group; Age-matched healthy male volunteers without inflammatory rheumatic disease.	Other: No Treatment (Healthy Controls); No pharmacological treatment; healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain Assessed by LANSS Score	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.	Baseline
Quality of Life Assessed by Ankylosing Spondylitis Quality of Life (ASQoL) Score	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.	baseline
Disease Activity Assessed by BASDAI Score	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.	Baseline
Functional Status Assessed by BASFI Score	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.	Baseline
Spinal Mobility Assessed by BASMI Score	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.	Baseline
Prevalence of Sexual Dysfunction Based on IIEF Cutoffs	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.	Baseline
Prevalence of Neuropathic Pain Based on LANSS Cutoffs	The proportion of participants with neuropathic pain will be determined using established LANSS cutoffs and compared among groups.	Baseline

Collaborators and Investigators

• Sponsor: Altuğ Güner

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): July 3, 2021
• Study Completion (Actual): July 3, 2021

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anti-TNF Therapy Tumor Necrosis Factor Inhibitors Erectile Dysfunction Quality of Life BASDAI IIEF LANSS NSAIDs Observational Study
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Urogenital Diseases; Genital Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Spondylitis, Ankylosing; Sexual Dysfunction, Physiological; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: UUTF-AS-TNF-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No