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

NCT07453628 | Completed

• 1 other identifier: UUTF-AS-TNF-2021
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

tudy Description Definitions Use this module to describe the study protocol.

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Conditions

Sexual Dysfunction; Ankylosing Spondylitis

Keywords

Anti-TNF Therapy Tumor Necrosis Factor Inhibitors Erectile Dysfunction Quality of Life BASDAI IIEF LANSS NSAIDs Observational Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

Anti-TNF Therapy Group

Male patients with ankylosing spondylitis receiving anti-tumor necrosis factor therapy for at least 3 months.

Drug: Anti-TNF agents

NSAID Group

Male patients with ankylosing spondylitis receiving only nonsteroidal anti-inflammatory drugs for at least 3 months.

Drug: NSAIDs

Healthy Control Group

Age-matched healthy male volunteers without inflammatory rheumatic disease.

Other: No Treatment (Healthy Controls)

Interventions

Anti-TNF agents DRUG

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

Anti-TNF Therapy Group

NSAIDs DRUG

Nonsteroidal anti-inflammatory drugs used as standard treatment.

NSAID Group

No Treatment (Healthy Controls) OTHER

No pharmacological treatment; healthy volunteers.

Healthy Control Group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altuğ Güner: lead

Study Sites (1)

Uludag University Faculty of Medicine

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Sexual Dysfunction, Physiological

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Uludag University Faculty of Medicine

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: February 3, 2021
• Primary Completion: July 3, 2021
• Study Completion: July 3, 2021
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)