Betadine vs Sterile Water for Periurethral Preparation

Not Applicable

Not yet recruiting

• Conditions: Catherization; Urinary Tract Infection Bacterial
• Interventions: Drug: Povidone-Iodine; Drug: Sterile water

• Registration Number: NCT07044726
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water (water that has been treated to remove bacteria and living organisms) vs Betadine also known as Povidone-Iodine (a medical grade cleaning solution) changes the rates of bacteria in the urine after a temporary catheter, or draining tube, is placed into the bladder. Chemical antiseptics, including Betadine, are the current standard of care. An additional goal of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water vs betadine changes the amount of discomfort or pain patients experience with placement of a temporary catheter, or draining tube, in the bladder.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study Start: 2025-06-23
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2028-05-21
• Study Completion: 2028-05-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

• Aged 18+
• Patient undergoing in office straight catherization

Exclusion Criteria

• History of culture proven recurrent urinary tract infection (2 in any 6-month period or 3 in any 12-month period)
• Urine Analysis with +Nitrites
• Catherization for any reason in the last 4 weeks
• History of Iodine allergy
• Patients unable to speak English
• Patient does not have the capacity to consent
• 2-3rd trimester pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Betadine	Povidone-Iodine	Betadine periurethral preparation
Sterile Water	Sterile water	Sterile Water periurethral preparation

Primary Outcome Measures

Name	Time	Method
Bacteruria	Within 2 weeks of the patients procedure date	Bacteruria defined as the presence of bacteria within patient urine evaluated with urinalysis. Bacterial presence will be further characterized by colony forming unit count on urine culture.

Secondary Outcome Measures

Name	Time	Method
Urethral Pain	At the time of catherization	Urethral pain at the time of catheterization rated by patients on a visual analog scale zero to ten with zero representing no pain and ten representing the worst pain of their life.

Trial Locations

Locations (2)

UofL Physicians - Urogynecology Springs Urogynecology Office; 🇺🇸 Louisville, Kentucky, United States

UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 4; 🇺🇸 Louisville, Kentucky, United States