Chlorhexidine lavage to prevent recurrent urinary tract infections in post-menopausal women
Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women with Recurrent Urinary Tract Infection
This study is testing if using a special wash called chlorhexidine can help post-menopausal women on vaginal estrogen therapy prevent recurring urinary tract infections better than just using water.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 55 Years to 89 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06598514 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 2% chlorhexidine perineal lavage compared to water lavage in reducing recurrent urinary tract infections (UTIs) among post-menopausal women who are already on vaginal estrogen therapy. The study involves a two-arm randomized control design, where participants will be monitored for up to six months, with UTI occurrences tracked through culture-proven samples. The aim is to identify a low-cost, non-antibiotic intervention that can help prevent UTIs in this population, addressing a significant healthcare need.
Who should consider this trial
Good fit: Ideal candidates for this study are post-menopausal women aged 55 to 89 who have a history of recurrent urinary tract infections and are currently using vaginal estrogen therapy.
Not a fit: Patients with complicated urinary tract conditions, recent antibiotic use, or those who are non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of recurrent UTIs in post-menopausal women, improving their quality of life and reducing reliance on antibiotics.
How similar studies have performed: While the use of vaginal estrogen for UTI prevention has been established, the specific approach of chlorhexidine lavage is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.