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Active Not RecruitingNCT06598514

Chlorhexidine Lavage for Recurrent Urinary Tract Infection

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

Status
Active Not Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
136 (estimated)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
Female
Age
55 Years – 89 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGChlorhexidineParticipants will use a 2% chlorhexidine perineal lavage following defecation
DRUGSterile WaterParticipants will use a sterile water perineal lavage following defecation

Timeline

Start date
2024-12-23
Primary completion
2026-04-01
Completion
2026-06-01
First posted
2024-09-19
Last updated
2026-01-15

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06598514. Inclusion in this directory is not an endorsement.