Betadine vs Sterile Water for Catheterization

Not yet recruiting at 1 trial location
KC
Overseen ByKathryn C Seymour, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of different cleaning methods before placing a temporary catheter into the bladder. It compares cleaning with Betadine (Povidone-Iodine, a common antiseptic) and sterile water to determine which method results in fewer bacteria in the urine and less discomfort for patients. The goal is to assess whether sterile water can be as effective and comfortable as Betadine. Suitable participants are those requiring an in-office catheter procedure without a history of frequent urinary tract infections. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to enhance patient comfort and effectiveness.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that Povidone-Iodine, also known as Betadine, is generally safe for use on the skin. This common antiseptic prevents infections and has proven effective for cleaning the skin before medical procedures. When used with catheters, it helps lower infection risk.

Comparisons with another antiseptic, Chlorhexidine, reveal that some studies suggest Chlorhexidine might be slightly more effective in preventing infections. However, both are considered safe and widely used.

For those considering joining a trial involving Povidone-Iodine, it is important to know that it has a strong safety record. While some people might experience minor skin irritation, serious side effects are rare.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores the effectiveness of two different periurethral preparation solutions for catheterization: Betadine and sterile water. Betadine, which contains povidone-iodine, is known for its strong antiseptic properties, potentially reducing the risk of infection. On the other hand, sterile water offers a simpler, non-antiseptic approach, which might be beneficial for patients with sensitivities to iodine or other antiseptics. By comparing these two methods, the study aims to provide insights into whether a non-antiseptic option could be just as effective or preferable in certain situations, potentially broadening the scope of catheterization preparation methods.

What evidence suggests that this trial's treatments could be effective for reducing bacteria and discomfort during catheterization?

Research has shown that Povidone-Iodine, also known as Betadine, effectively reduces infections when used with catheters. One study found that Povidone-Iodine significantly lowered infection rates from catheters by inhibiting bacterial growth when a catheter is placed in the bladder. In this trial, one group of participants will receive Betadine for periurethral preparation, while another group will receive sterile water. Sterile water primarily cleans and removes bacteria but does not kill bacteria like Betadine. The trial aims to determine if sterile water is as effective as Betadine in preventing bacteria in urine after catheter use.26789

Who Is on the Research Team?

AG

Ankita Gupta, MD, MPH

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals who require a temporary urinary catheter and are at risk of UTIs. Participants must be eligible for catheterization without any known allergies to Betadine or Povidone-Iodine, and should not have conditions that could interfere with the study outcomes.

Inclusion Criteria

I am having a catheter placed in a doctor's office.
I am 18 years old or older.

Exclusion Criteria

Urine Analysis with +Nitrites
Catheterization for any reason in the last 4 weeks
History of Iodine allergy
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo periurethral preparation with either Betadine or Sterile Water followed by catheterization

1 day
1 visit (in-person)

Follow-up

Participants are monitored for bacteruria and urethral pain after catheterization

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Povidone-Iodine
  • Sterile water
Trial Overview The study aims to compare the effectiveness of using sterile water versus Betadine (Povidone-Iodine) in reducing bacteria levels and pain during urethral cleaning before catheter insertion. It will assess if sterile water can be an alternative to chemical antiseptics.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: BetadineActive Control1 Intervention
Group II: Sterile WaterPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30570800/
Povidone-iodine lowers the incidence of catheter- ...Conclusion: The incidence of infection caused by CV catheters was significantly reduced using povidone-iodine; therefore, we recommend this procedure as part ...
A Randomized Trial of Betadine Bladder Irrigations vs. ...Bacteriuria increases by 3-10% each day a catheter is left in place1, 2 meaning that by 30 days, generally 100% of patients with indwelling catheters will have ...
Alcoholic povidone-iodine or chlorhexidine-based ...The study included 806 CVC (CBA period: 371). Upon switching from PVP-IA to CBA, we recorded a significant reduction in colonization incidence/100 catheter days ...
Comparison of the efficacy of three topical antiseptic solutions ...Outcomes. The primary outcome of this study is catheter colonization incidence per 1000 catheter-days at the time of catheter removal. ...
Effectiveness of 10% povidone-iodine drying time before ...In total, 53 patients were enrolled, 25 were exposed to a 2-m drying time and 28 to a 30-s drying time. From the preliminary results of this study, no ...
Skin antisepsis for reducing central venous catheter‐related ...Skin cleansing with chlorhexidine solution may reduce rates of CRBSI and catheter colonisation compared with cleaning with povidone iodine. These results are ...
Chlorhexidine solutions are more effective than povidone ...The findings indicated that CHG-containing solutions were more effective than PVI-containing solutions in preventing catheter-related sepsis or ...
Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for ...SSIs were identified in 80 patients (5.1%) in the povidone iodine group vs 97 (5.5%) in the chlorhexidine gluconate group, a difference of 0.4% ...
Review Chlorhexidine and povidone-iodine: Unmasking ...This review provides a comprehensive synthesis of the comparative efficacy, safety, and practical considerations of CHG and PVI for intravascular catheter ...
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