Chlorhexidine Lavage for Recurrent Urinary Tract Infection

NCT06598514 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00027352
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Recurrent Urinary Tract Infection

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vulvovaginal Symptom Questionnaire (VSQ)

  VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

• Urinary Distress Inventory (UDI-6)

  UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization

Other Outcomes (1)

• Participant Satisfaction with Virtual Recruitment

  Upon completion of the intervention period, 90 days after randomization

Study Arms (2)

Chlorhexidine Lavage

EXPERIMENTAL

2% chlorhexidine perineal lavage following defecation

Drug: Chlorhexidine

Sterile Water Lavage

ACTIVE COMPARATOR

Sterile water perineal lavage following defecation

Drug: Sterile Water

Interventions

Chlorhexidine DRUG

Participants will use a 2% chlorhexidine perineal lavage following defecation

Chlorhexidine Lavage

Sterile Water DRUG

Participants will use a sterile water perineal lavage following defecation

Sterile Water Lavage

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their assigned treatment. All participants will receive a box containing their randomized intervention and identical use instructions. Opaque bottles will contain either a sterile water solution or 2% chlorhexidine. Spray bottles will be identical in external appearance.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individuals meeting inclusion criteria will be randomized to the treatment (2% chlorhexidine perineal lavage following defecation) or control (sterile water perineal lavage following defecation) and rates of urinary tract infection will be compared. Balanced randomization will be performed via computer-generated assignments in REDCap with random permuted blocks varying in size between 8 and 10.

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: December 23, 2024
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)