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

Trial Summary

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 data supports the effectiveness of the treatment Chlorhexidine for recurrent urinary tract infections?

Chlorhexidine has been shown to significantly reduce bacteriuria (bacteria in urine) in spinally injured patients when used as an antiseptic wash, and it effectively prevents catheter-associated urinary infections when used in a special catheter. However, some bacteria causing urinary infections can be resistant to chlorhexidine. ^{1 2 3 4 5}

Is chlorhexidine generally safe for humans?

Chlorhexidine is generally safe for use, but there have been rare cases of severe allergic reactions (anaphylaxis) reported, especially during procedures like catheterization. Some people may also experience irritation or a burning sensation when it is applied to sensitive areas. ^{1 5 6 7 8}

How does the treatment chlorhexidine differ from other treatments for recurrent urinary tract infections?

Chlorhexidine is unique because it is an antiseptic used for cleansing rather than a traditional antibiotic, and it has been shown to reduce certain bacteria in specific settings, although it may not be effective for all types of bacteria or suitable for prolonged use in the bladder. ^{1 4 9 10 11}

What is the purpose of this trial?

A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.

Eligibility Criteria

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.

My condition is a severe pelvic organ prolapse.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. England 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. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Antiseptic and antibiotic resistance in gram-negative bacteria causing urinary tract infection in spinal cord injured patients. [2004]

3. Japan pubmed.ncbi.nlm.nih.gov

[Efficacy of a latex Foley catheter with sustained release of chlorhexidine: 1st report: Clinical trials for the prevention of urinary tract infection]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Antimicrobial effect of chlorhexidine on bacteria of groin, perineum and vagina. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical application of skin antisepsis using aqueous olanexidine: a scoping review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

The danger of chlorhexidine in lignocaine gel: A case report of anaphylaxis during urinary catheterisation. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The effect of chlorhexidine irrigation of the bladder in the rat. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

The effect of repeated instillations of antiseptics on catheter-associated urinary tract infections: a study in a physical model of the catheterized bladder. [2022]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of antimicrobial preparations in preventing infectious wound complications after an operation on the kidney and upper urinary tract]. [2009]