Lower Urinary Tract Symptoms in Males Living With HIV

• Sponsor: Koç University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05964803
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity; Lower Urinary Tract Symptoms	Diagnostic Test: Questionnaires

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Males Living With HIV and LUTS: A Case-control Study.
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	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).

Outcome Measures

Primary Outcome Measures

1. Questionnaires [Once]

   International Consultation on Incontinence Questionnaire

2. Questionnaires [Once]

   Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

3. Questionnaires [Once]

   ICIQ-Short Form (ICIQ-SF)

4. Questionnaires [Once]

   International Prostate Symptom Score (IPSS)

5. Questionnaires [Once]

   King's Healthcare Questionnaire (KHQ)

6. Questionnaires [Once]

   8-item Overactive Bladder Questionnaire (OAB-V8)

7. Questionnaires [Once]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients above 18 years old

Exclusion Criteria:

• Non-Turkish speakers

• Previous surgeries or medications for lower urinary tract symptoms

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Koç University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ersin Köseoglu, MD, Koç University
• ClinicalTrials.gov Identifier: NCT05964803
• Other Study ID Numbers: KocUrol5
• First Posted: Jul 28, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Seropositivity; Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Jul 28, 2023