Chlorhexidine Lavage for Recurrent Urinary Tract Infection

NCT ID: NCT06598514

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2026-06-30

Brief Summary

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

Detailed 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.

Conditions

Urinary Tract Infections; Recurrent Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Chlorhexidine Lavage

2% chlorhexidine perineal lavage following defecation

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

Participants will use a 2% chlorhexidine perineal lavage following defecation

Sterile Water Lavage

Sterile water perineal lavage following defecation

Group Type: ACTIVE_COMPARATOR

Sterile Water

Intervention Type: DRUG

Participants will use a sterile water perineal lavage following defecation

Interventions

Chlorhexidine

Participants will use a 2% chlorhexidine perineal lavage following defecation

Intervention Type: DRUG

Sterile Water

Participants will use a sterile water perineal lavage following defecation

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Sara Cichowski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

STUDY00027352

Identifier Type: -

Identifier Source: org_study_id