Clinical trial NCT06598514: Chlorhexidine Lavage for Recurrent Urinary Tract Infection
Official title: Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women with Recurrent Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Tract Infections
Recurrent Urinary Tract Infection
Keywords: Menopause
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 136
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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. 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.

Eligibility 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)

Primary outcomes:
measure: Rate of Urinary Tract Infection (UTI)
timeFrame: 90 days following treatment initiation
Secondary outcomes:
measure: Vulvovaginal Symptom Questionnaire (VSQ)
timeFrame: VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
measure: Urinary Distress Inventory (UDI-6)
timeFrame: UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization
Other outcomes:
measure: Participant Satisfaction with Virtual Recruitment
timeFrame: Upon completion of the intervention period, 90 days after randomization
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: