A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
136
Participants will use a 2% chlorhexidine perineal lavage following defecation
Participants will use a sterile water perineal lavage following defecation
Oregon Health & Science University
Portland, Oregon, United States
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
Time frame: 90 days following treatment initiation
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.
Time frame: 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.
Time frame: UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
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