NCT05964803

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

July 9, 2023

Last Update Submit

April 15, 2024

Conditions

HIV SeropositivityLower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (7)

  • Questionnaire 1

    International Consultation on Incontinence Questionnaire

    Day 1

  • Questionnaire 2

    Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

    Day 1

  • Questionnaire 3

    ICIQ-Short Form (ICIQ-SF)

    Day 1

  • Questionnaire 4

    International Prostate Symptom Score (IPSS)

    Day 1

  • Questionnaire 5

    King's Healthcare Questionnaire (KHQ)

    Day 1

  • Questionnaire 6

    8-item Overactive Bladder Questionnaire (OAB-V8)

    Day 1

  • Questionnaire 7

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

    Day 1

Study Arms (2)

Males living with HIV

Males living with HIV and followed by infectious diseases clinic will be directed to Urology department.

Diagnostic Test: Questionnaires

HIV-negative controls

Males admitted to Infectious Diseases clinic and documented to be HIV-negative.

Diagnostic Test: Questionnaires

Interventions

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).

HIV-negative controlsMales living with HIV

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales above 18 years old
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients above 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HIV SeropositivityLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 28, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)