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Completed

NCT Number: NCT05964803

Lower Urinary Tract Symptoms in Males Living With HIV

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.

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Key information

Conditions

HIV Seropositivity Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Urological Manifestations Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients above 18 years old

Exclusion criteria

  • Non-Turkish speakers
  • Previous surgeries or medications for lower urinary tract symptoms

Treatment and study plan

Questionnaires

Diagnostic 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).

Primary outcomes

  1. Questionnaire 1

    Time frame: Day 1

    International Consultation on Incontinence Questionnaire

  2. Questionnaire 2

    Time frame: Day 1

    Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

  3. Questionnaire 3

    Time frame: Day 1

    ICIQ-Short Form (ICIQ-SF)

  4. Questionnaire 4

    Time frame: Day 1

    International Prostate Symptom Score (IPSS)

  5. Questionnaire 5

    Time frame: Day 1

    King's Healthcare Questionnaire (KHQ)

  6. Questionnaire 6

    Time frame: Day 1

    8-item Overactive Bladder Questionnaire (OAB-V8)

  7. Questionnaire 7

    Time frame: Day 1

    Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

Males Living With HIV and LUTS: A Case-control Study.

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
Apr 17, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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