Chlorhexidine for Recurrent Urinary Tract Infections

Overseen By Women's Health Research Unit Department of Ob/Gyn

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must be taking: Vaginal estrogen

Must not be taking: Prophylactic antibiotics

Disqualifiers: Neurogenic bladder, Urinary retention, Prolapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 12 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of chlorhexidine (an antiseptic wash) in reducing urinary tract infections (UTIs) in post-menopausal women already using vaginal estrogen. It compares two treatments: a chlorhexidine wash and a sterile water wash, both used after bathroom visits, to determine which method better prevents UTIs. Women who have recently experienced multiple UTIs, are on vaginal estrogen, and currently show no UTI symptoms might be suitable candidates. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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

The trial requires a 4-week period without using preventive antibiotics before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What is the safety track record for Chlorhexidine?

Research has shown that chlorhexidine is usually safe as a cleaning agent. Hospitals commonly use it to clean skin before surgeries and to treat gum disease. Most people do not experience serious side effects, though some may have mild skin irritation.

Researchers are also investigating chlorhexidine's potential to prevent urinary tract infections (UTIs), particularly those associated with catheters. These studies aim to determine if it can reduce infection rates without causing significant side effects.

Since this study is in a later phase, earlier research has already assessed chlorhexidine's safety, providing some confidence in its use for this new purpose. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for recurrent urinary tract infections (UTIs) involve antibiotics, which work by killing or stopping the growth of bacteria. However, the overuse of antibiotics can lead to resistance and other side effects. Researchers are excited about using chlorhexidine lavage as it presents a novel approach by using a 2% chlorhexidine solution for perineal cleaning after defecation. Chlorhexidine has antimicrobial properties that can help reduce bacterial presence without the risk of antibiotic resistance. This method might offer a safer and more sustainable way to manage recurrent UTIs.

What evidence suggests that this trial's treatments could be effective for recurrent urinary tract infections?

This trial will compare the effectiveness of chlorhexidine lavage with sterile water lavage in preventing recurrent urinary tract infections (UTIs). Research has shown mixed results regarding chlorhexidine's ability to reduce UTIs. One study found that a 0.05% solution of chlorhexidine did not significantly lower the risk of UTIs. However, another study suggested that antiseptics like chlorhexidine might help reduce UTIs. Chlorhexidine is often used to kill or inhibit the growth of germs. While it shows potential, more evidence is needed to confirm its effectiveness in preventing recurring UTIs. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

No post-menopausal bleeding

Ready access to email and internet

Exclusion Criteria

Non-English speaking

I have had serious urinary tract infections before.

Indwelling catheter or need for intermittent self-catheterization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a 2% chlorhexidine perineal lavage or a water lavage following defecation

12 weeks

Visits at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for urinary tract infections and vulvovaginal symptoms

12 weeks

Visit at 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine

Trial Overview 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.

How Is the Trial Designed?

Group I: Chlorhexidine Lavage Experimental Treatment 1 Intervention

2% chlorhexidine perineal lavage following defecation

Group II: Sterile Water Lavage Active Control 1 Intervention

Sterile water perineal lavage following defecation

Chlorhexidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Approved in United States as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Approved in Canada as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Approved in Japan as Chlorhexidine for:

• Preoperative skin preparation
• Hand hygiene
• Mouthwash
• Dental plaque control
• Gingivitis treatment
• Skin infections
• Wound care

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study involving 154 obstetric patients, both Hibiclens and Hibitane Tincture demonstrated over 99% bacterial kill rates on skin bacteria within 10 and 30 minutes of application, indicating their strong antimicrobial efficacy.

Hibitane Tincture caused vulvar irritation due to its high isopropanol content, making it unsuitable as a perigenital antiseptic, while Hibiclens showed no side effects and is considered a promising antiseptic for obstetric and gynecologic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial effect of chlorhexidine on bacteria of groin, perineum and vagina. Vorherr, H., Ulrich, JA., Messer, RH., et al.[2013]

Irrigation of rat bladders with chlorhexidine digluconate solutions (1:5,000 and 1:10,000) for up to 48 hours resulted in severe erosive cystitis in many cases, indicating significant tissue damage.

The study concludes that chlorhexidine should not be used for prolonged bladder irrigation or during intermittent catheterization due to its harmful effects on the bladder mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chlorhexidine irrigation of the bladder in the rat. Harper, WE., Matz, LR.[2019]

A randomized controlled trial involving 20 home care patients found no significant difference in urinary tract infection risk between using 0.05% chlorhexidine gluconate (CHG) and sterile water for periurethral cleansing before catheterization.

None of the participants developed symptomatic bacteriuria, indicating that using sterile water is a safe alternative for cleansing without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. Cheung, K., Leung, P., Wong, YC., et al.[2013]

In spinally injured patients undergoing intermittent catheterization, daily chlorhexidine antisepsis significantly reduced bacteriuria from 74% to 60% in male patients not on antibiotics (P < 0.01).

However, chlorhexidine did not affect perineal colonization by coliforms or environmental contamination, indicating that while it helps reduce urinary infections, it may not impact overall bacterial presence in the perineal area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effect of chlorhexidine antisepsis, soap and antibiotics on bacteriuria, perineal colonization and environmental contamination in spinally injured patients. Sanderson, PJ., Weissler, S.[2019]

An 84-year-old man experienced anaphylaxis after receiving Instillagel(®) for urethral catheterization, highlighting a serious allergic reaction to chlorhexidine, one of its active ingredients.

This case emphasizes that even patients with prior uneventful exposures to chlorhexidine can develop sensitization, leading to unexpected anaphylactic reactions during subsequent uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. Dyer, JE., Nafie, S., Mellon, JK., et al.[2021]

Citations

1. withpower.com withpower.com/trial/chlorhexidine-for-recurrent-urinary-tract-infections-4e358

Chlorhexidine for Recurrent Urinary Tract Infections A randomized controlled trial involving 20 home care patients found no significant difference in urinary tract infection risk between using 0.05% chlorhexidine ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557479/

Recurrent Urinary Tract Infections - StatPearls - NCBI Bookshelf The oral vaccine, MV140, has shown good efficacy in preventing recurrent UTIs in several studies with safety data and minimal adverse effects. A preliminary ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196655321000225

Major Article The frequency of urinary tract infections and ... One of the 2 studies exploring the benefit of antiseptics in reducing UTI suggest some potential benefit of using chlorhexidine in reducing UTIs. Both studies ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06598514/chlorhexidine-lavage-for-recurrent-urinary-tract-infection

Chlorhexidine Lavage for Recurrent Urinary Tract Infection The current most effective non-antibiotic prophylaxis for recurrent UTI is vaginal estrogen; however, approximately 50% of women will continue ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05712434

Chlorhexidine to Prevent Catheter-related Urinary Tract ... The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) ...

6. go.drugbank.com go.drugbank.com/drugs/DB00878

Chlorhexidine: Uses, Interactions, Mechanism of Action Chlorhexidine is an antiseptic used to sterilize for surgeries and in healthcare practice, to reduce pocket depth in periodontitis, and to treat gingivitis.

7. uroweb.org uroweb.org/guidelines/urological-infections/chapter/the-guideline

EAU Guidelines on Urological Infections Patients with ABU and recurrent UTI, otherwise healthy. One RCT investigated the effect of ABU treatment in female patients with recurrent symptomatic UTI ...

8. ajog.org ajog.org/article/S0002-9378(21)02736-8/pdf

Chlorhexidine gluconate vaginal preparation to prevent ... We aimed to evaluate antibiotic resistance and tolerability in women with recurrent UTI treated with “prolonged” continuous antibiotic prophylaxis, defined as ...