Chlorhexidine Lavage for Recurrent Urinary Tract Infection

Oregon Health & Science University (OHSU)

Status and phase: Active, not recruiting; Phase 4

Conditions: Urinary Tract Infections; Recurrent Urinary Tract Infection

Treatments: Drug: Chlorhexidine; Drug: Sterile Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06598514

STUDY00027352

Details and patient eligibility

About

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

Full description

There is a critical need for low-cost, non-antibiotic interventions that are feasible for patients to utilize for risk reduction and prevention of recurrent urinary tract infections (UTIs). The current most effective non-antibiotic prophylaxis for recurrent UTI is vaginal estrogen; however, approximately 50% of women will continue to experience UTIs. The investigators propose a randomized control trial of postmenopausal women on vaginal estrogen with the diagnosis of recurrent UTIs to evaluate a novel post-defecation hygienic strategy utilizing a 2% chlorhexidine perineal lavage. Participants will be randomized to either a 2% chlorhexidine perineal lavage or a water lavage. Study participants will be followed for up to 6-months, and UTIs will be tracked with culture proven samples throughout study participation.

Enrollment: 136 estimated patients

Sex: Female

Ages: 55 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post-menopausal female between age 55 and 89
• No post-menopausal bleeding
• 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
• At least one UTI in the 6 months prior to entering the study
• Asymptomatic for UTI symptoms at the time of enrollment.
• On vaginal estrogen therapy for at least 6 weeks prior to enrollment
• Ready access to email and internet

Exclusion criteria

• Recent prophylactic antibiotic use (washout period of 4 weeks)
• Neurogenic bladder
• Diagnosis of urinary retention
• Uncorrected Stage III-IV prolapse
• Indwelling catheter or need for intermittent self-catheterization
• History of complicated UTIs
• History of interstitial cystitis or bladder pain syndrome
• History of fecal incontinence/accidental bowel leakage
• Greater than 14 bowel movements per week
• Non-English speaking
• Allergy to chlorhexidine gluconate
• Inability to utilize vaginal estrogen therapy
• Recent urogynecological or urologic surgery (<12 weeks)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Chlorhexidine Lavage

Experimental group

Description:

2% chlorhexidine perineal lavage following defecation

Treatment:

Drug: Chlorhexidine

Sterile Water Lavage

Active Comparator group

Description:

Sterile water perineal lavage following defecation

Treatment:

Drug: Sterile Water