Chlorhexidine Lavage for Recurrent Urinary Tract Infection
- Conditions
- Urinary Tract InfectionsRecurrent Urinary Tract Infection
- Interventions
- Registration Number
- NCT06598514
- Lead Sponsor
- Oregon Health and Science University
- 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. We 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 136
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chlorhexidine Lavage Chlorhexidine 2% chlorhexidine perineal lavage following defecation Sterile Water Lavage Sterile Water Sterile water perineal lavage following defecation
- Primary Outcome Measures
Name Time Method Rate of Urinary Tract Infection (UTI) 90 days following treatment initiation The proportion of participants in each arm who experience a urinary tract infection (UTI) within 90 days will be compared
- Secondary Outcome Measures
Name Time Method Vulvovaginal Symptom Questionnaire (VSQ) VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization 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.
Urinary Distress Inventory (UDI-6) UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization 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.
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States