Ankylosing SpondylitisNCT07453628
Association of Erectile Dysfunction With Neuropathic Pain, Disease Activity, and Functional Status in Male Patients With Axial Spondyloarthritis: A Cross-Sectional Observational Study
An observational study of Ankylosing Spondylitis and Sexual Dysfunction, run by Altuğ Güner at 1 site in Turkey (Türkiye).
Trial summary
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 Use these resources to provide understandable information about this study to patients, families, and health care providers… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Sexual Dysfunction
- What is being tested?
- Anti-TNF agents and NSAIDs
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 3 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uludag University Faculty of Medicine
Bursa, 16059
About this study
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
*
Use these resources to provide understandable information about this study to patients, families, and health care providers:
Plain language checklist for Brief Summary Template for Brief Summary
5,000 characters allowed Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.
32,000 characters allowed Save Changes Clear Unsaved Changes
Read the 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:
- 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.
- Conditions
- Ankylosing Spondylitis, Sexual Dysfunction
- Being tested
- Anti-TNF agents, NSAIDs, No Treatment (Healthy Controls)
- Keywords
- Anti-TNF Therapy Tumor Necrosis Factor Inhibitors Erectile Dysfunction Quality of Life BASDAI IIEF LANSS NSAIDs Observational Study
- Medical subject headings
- Spondylitis, Ankylosing, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF agentsDrug
Ongoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care.
NSAIDsDrug
Nonsteroidal anti-inflammatory drugs used as standard treatment.
No Treatment (Healthy Controls)Other
No pharmacological treatment; healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF Therapy Group | Male patients with ankylosing spondylitis receiving anti-tumor necrosis factor therapy for at least 3 months. Receives: Drug: Anti-TNF agents | |
| NSAID Group | Male patients with ankylosing spondylitis receiving only nonsteroidal anti-inflammatory drugs for at least 3 months. Receives: Drug: NSAIDs | |
| Healthy Control Group | Age-matched healthy male volunteers without inflammatory rheumatic disease. Receives: Other: No Treatment (Healthy Controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start3 Feb 2021
- Primary completion3 Jul 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altuğ Güner
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Altuğ Güner, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453628
- Sponsor's protocol ID
- UUTF-AS-TNF-2021
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Erectile Dysfunction With Neuropathic Pain, Disease Activity, and Functional Status in Male Patients With Axial Spondyloarthritis: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07453628
- Acronym / sponsor ID
- UUTF-AS-TNF-2021
- Conditions
- Ankylosing Spondylitis, Sexual Dysfunction
- Keywords
- Anti-TNF Therapy Tumor Necrosis Factor Inhibitors Erectile Dysfunction Quality of Life BASDAI IIEF LANSS NSAIDs Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Altuğ GünerOther government
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
*
Use these resources to provide understandable information about this study to patients, families, and health care providers:
Plain language checklist for Brief Summary Template for Brief Summary
5,000 characters allowed Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.
32,000 characters allowed Save Changes Clear Unsaved Changes
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF Therapy Group | – | Drug: Anti-TNF agentsMale patients with ankylosing spondylitis receiving anti-tumor necrosis factor therapy for at least 3 months. |
| NSAID Group | – | Drug: NSAIDsMale patients with ankylosing spondylitis receiving only nonsteroidal anti-inflammatory drugs for at least 3 months. |
| Healthy Control Group | – | Other: No Treatment (Healthy Controls)Age-matched healthy male volunteers without inflammatory rheumatic disease. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TNF agentsOngoing anti-tumor necrosis factor therapy prescribed as part of routine clinical care. | Drug | Anti-TNF Therapy Group |
| NSAIDsNonsteroidal anti-inflammatory drugs used as standard treatment. | Drug | NSAID Group |
| No Treatment (Healthy Controls)No pharmacological treatment; healthy volunteers. | Other | Healthy Control Group |
Primary outcome
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.
7 secondary outcomes
Neuropathic Pain Assessed by LANSS Score
Time frame: Baseline
Quality of Life Assessed by Ankylosing Spondylitis Quality of Life (ASQoL) Score
Time frame: baseline
Disease Activity Assessed by BASDAI Score
Time frame: Baseline
Functional Status Assessed by BASFI Score
Time frame: Baseline
Spinal Mobility Assessed by BASMI Score
Time frame: Baseline
Prevalence of Sexual Dysfunction Based on IIEF Cutoffs
Time frame: Baseline
Prevalence of Neuropathic Pain Based on LANSS Cutoffs
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Sexual Dysfunction, run by Altuğ Güner at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Function Assessed by International Index of Erectile Function (IIEF) Total Score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.