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Antiseptic

Chlorhexidine for Recurrent Urinary Tract Infections

Phase 4

Waitlist Available

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menopausal female between age 55 and 89

Diagnosis of recurrent urinary tract infection (UTI) in the electronic health record or as two culture proven UTIs in 6 months or three culture proven UTIs in 12 months

Must not have

Neurogenic bladder

History of complicated UTIs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up udi-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

"This trial is looking at how often post-menopausal women who have recurrent urinary tract infections get urinary tract infections while using vaginal estrogen."

Who is the study for?

This trial is for post-menopausal women who are using vaginal estrogen and have had multiple urinary tract infections. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

What is being tested?

The study is testing whether rinsing with Chlorhexidine or Sterile Water affects the rate of recurrent urinary tract infections in the target group. It's a two-arm trial, meaning there are two groups: one using Chlorhexidine and one using Sterile Water.

What are the potential side effects?

Potential side effects aren't listed, but generally, Chlorhexidine can cause mild skin irritation or allergic reactions. Since it's used as a rinse here, it may also lead to local discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 55-89 and have gone through menopause.

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I have had multiple UTIs diagnosed or proven by tests in the past year.

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I have had a urinary tract infection in the last 6 months.

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I do not have symptoms of a urinary tract infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition where my bladder doesn't function properly due to nerve damage.

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I have had serious urinary tract infections before.

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My condition is a severe pelvic organ prolapse.

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I have been diagnosed with urinary retention.

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I have more than 14 bowel movements a week.

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I have a history of bladder pain or interstitial cystitis.

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I cannot use vaginal estrogen therapy.

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I have a history of accidental bowel leakage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ vsq administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~vsq administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and vsq administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization for reporting.