Chlorhexidine Lavage for Recurrent Urinary Tract Infection

Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection

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

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Tract Infections; Recurrent Urinary Tract Infection
• Intervention / Treatment: Drug: Chlorhexidine; Drug: Sterile Water

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.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine Lavage; 2% chlorhexidine perineal lavage following defecation	Drug: Chlorhexidine; Participants will use a 2% chlorhexidine perineal lavage following defecation
Active Comparator: Sterile Water Lavage; Sterile water perineal lavage following defecation	Drug: Sterile Water; Participants will use a sterile water perineal lavage following defecation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Urinary Tract Infection (UTI)	The proportion of participants in each arm who experience a urinary tract infection (UTI) within 90 days will be compared	90 days following treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vulvovaginal Symptom Questionnaire (VSQ)	Vulvovaginal symptoms will be evaluated using the VSQ from baseline to post-intervention and compared between the groups with and without chlorhexidine in their perineal lavage. The VSQ is scored on a scale of 0-16 for those who are not sexually active or 0-20 for those who are sexually active, with a higher score indicating worse outcomes.	VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Urinary Distress Inventory (UDI-6)	Urinary symptoms will be evaluated using the UDI-6 from baseline to post-intervention and compared between the groups with and without chlorhexidine in their perineal lavage. It is scored on a scale from 0 to 100 with higher scores indicating worse outcomes.	UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction with Virtual Recruitment	Satisfaction with virtual recruitment and enrollment will be evaluated using the Patient Global Impression scales to allow for participant reported outcomes regarding perceived change following intervention. It is scored on a scale from 1 to 7 with a higher score indicating a worse outcome.	Upon completion of the intervention period, 90 days after randomization

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Menopause
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Organic Chemicals; Biguanides; Guanidines; Amidines; Chlorhexidine
• Other Study ID Numbers: STUDY00027352

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No