Betadine vs Sterile Water for Periurethral Preparation

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT07044726
Phase
PHASE4
Status
Recruiting

Conditions

  • Catherization
  • Urinary Tract Infection Bacterial

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Povidone-Iodine — DRUG
    Providone-Iodine for periurethral preparation
  • Sterile water — DRUG
    Sterile water for periurethral preparation

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2026
Primary completion
May 21, 2028
Completion
May 21, 2028

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Betadine
    Betadine periurethral preparation
  • Sham Comparator: Sterile Water
    Sterile Water periurethral preparation

Primary Outcome Measure

Bacteruria [ Time Frame: Within 2 weeks of the patients procedure date ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UofL Health - Urogynecology Mary & Elizabeth Hospital, Medical Plaza 3LouisvilleKentucky40215
Kathryn Seymour, MD
502-588-7660
Ankita Gupta, MD (PRINCIPAL_INVESTIGATOR)
UofL Physicians - Urogynecology Springs Urogynecology OfficeLouisvilleKentucky40205
Kathryn Seymour, MD
502-588-7660
Ankita Gupta, MD (PRINCIPAL_INVESTIGATOR)

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