Lower Urinary Tract Symptoms in Males Living With HIV

April 15, 2024 updated by: Ersin Köseoglu, Koç University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34010
        • Koc University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients above 18 years old

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Males living with HIV
Males living with HIV and followed by infectious diseases clinic will be directed to Urology department.
Diagnostic test: Questionnaires
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).
HIV-negative controls
Males admitted to Infectious Diseases clinic and documented to be HIV-negative.
Diagnostic test: Questionnaires
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire 1
Time Frame: Day 1
International Consultation on Incontinence Questionnaire
Day 1
Questionnaire 2
Time Frame: Day 1
Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
Day 1
Questionnaire 3
Time Frame: Day 1
ICIQ-Short Form (ICIQ-SF)
Day 1
Questionnaire 4
Time Frame: Day 1
International Prostate Symptom Score (IPSS)
Day 1
Questionnaire 5
Time Frame: Day 1
King's Healthcare Questionnaire (KHQ)
Day 1
Questionnaire 6
Time Frame: Day 1
8-item Overactive Bladder Questionnaire (OAB-V8)
Day 1
Questionnaire 7
Time Frame: Day 1
Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

July 9, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KocUrol5

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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