HIV SeropositivityNCT05964803
Lower Urinary Tract Symptoms in Males Living With HIV
An observational study of HIV Seropositivity and Lower Urinary Tract Symptoms, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, Lower Urinary Tract Symptoms
- What is being tested?
- Questionnaires
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Jan 2024
- How long will I take part?
- 1 Day
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to Infectious Diseases Clinic (100 living with HIV, 100 HIV-negative males) will be directed to Urology clinic. The same questionnaires will be given and scores will be compared.
Who may be able to join
- Patients above 18 years old
Who cannot join
- Non-Turkish speakers
- Previous surgeries or medications for lower urinary tract symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Males Living With HIV and LUTS: A Case-control Study.
The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV.
- Conditions
- HIV Seropositivity, Lower Urinary Tract Symptoms
- Being tested
- Questionnaires
- Medical subject headings
- HIV Seropositivity, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
MLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
| Study group | Role | What they receive |
|---|---|---|
| Males living with HIV | Males living with HIV and followed by infectious diseases clinic will be directed to Urology department. Receives: Diagnostic Test: Questionnaires | |
| HIV-negative controls | Males admitted to Infectious Diseases clinic and documented to be HIV-negative. Receives: Diagnostic Test: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire 1
International Consultation on Incontinence Questionnaire
Measured: Day 1
Questionnaire 2
Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Measured: Day 1
Questionnaire 3
ICIQ-Short Form (ICIQ-SF)
Measured: Day 1
Questionnaire 4
International Prostate Symptom Score (IPSS)
Measured: Day 1
Questionnaire 5
King's Healthcare Questionnaire (KHQ)
Measured: Day 1
Questionnaire 6
8-item Overactive Bladder Questionnaire (OAB-V8)
Measured: Day 1
Questionnaire 7
Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Köseoglu, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964803
- Sponsor's protocol ID
- KocUrol5
- Status last verified
- Apr 2024
- First submitted
- 9 Jul 2023
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Males Living With HIV and LUTS: A Case-control Study.
- ClinicalTrials.gov ID
- NCT05964803
- Acronym / sponsor ID
- KocUrol5
- Conditions
- HIV Seropositivity, Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Jul 2023 (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.
The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males living with HIV | – | Diagnostic Test: QuestionnairesMales living with HIV and followed by infectious diseases clinic will be directed to Urology department. |
| HIV-negative controls | – | Diagnostic Test: QuestionnairesMales admitted to Infectious Diseases clinic and documented to be HIV-negative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Infectious Diseases Clinic (100 living with HIV, 100 HIV-negative males) will be directed to Urology clinic. The same questionnaires will be given and scores will be compared.
Key inclusion criteria (1 listed)
- Patients above 18 years old
Key exclusion criteria (2 listed)
- Non-Turkish speakers
- Previous surgeries or medications for lower urinary tract symptoms
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 |
|---|---|---|
| QuestionnairesMLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7). | Diagnostic test | HIV-negative controls, Males living with HIV |
Primary outcome
Questionnaire 1
Time frame: Day 1
International Consultation on Incontinence Questionnaire
Questionnaire 2
Time frame: Day 1
Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Questionnaire 3
Time frame: Day 1
ICIQ-Short Form (ICIQ-SF)
Questionnaire 4
Time frame: Day 1
International Prostate Symptom Score (IPSS)
Questionnaire 5
Time frame: Day 1
King's Healthcare Questionnaire (KHQ)
Questionnaire 6
Time frame: Day 1
8-item Overactive Bladder Questionnaire (OAB-V8)
Questionnaire 7
Time frame: Day 1
Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
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 17 Apr 2024.
- 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 HIV Seropositivity and Lower Urinary Tract Symptoms, run by Koç University 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 1 inclusion and 2 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 17 Apr 2024. 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?
Questionnaire 1 (time frame: Day 1). The study lists 7 primary outcomes in all. 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 17 Apr 2024.