Betadine vs Sterile Water for Periurethral Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2028-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal

NCT03447639

Catheter; Infection (Indwelling Catheter) Catheter Infection Catheter-Related Infections +2 more

TERMINATED PHASE4

Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection

NCT00259350

ICU Patients Requiring a Central Venous Access

COMPLETED PHASE4

Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

NCT03101371

Urinary Tract Infections Catheter Infection Catheter-Related Infections

COMPLETED PHASE2

Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

NCT00692484

Healthy

COMPLETED PHASE3

Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection

NCT05276687

Surgical Wound Infection

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Catherization Urinary Tract Infection Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Betadine

Betadine periurethral preparation

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

Providone-Iodine for periurethral preparation

Sterile Water

Sterile Water periurethral preparation

Group Type SHAM_COMPARATOR

Sterile water

Intervention Type DRUG

Sterile water for periurethral preparation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Povidone-Iodine

Providone-Iodine for periurethral preparation

Intervention Type DRUG

Sterile water

Sterile water for periurethral preparation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes