Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women
Condition: Recurrent Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Intervention: Conjugated Estrogen Vaginal Cream; Estradiol Ring; Placebo
Intervention MeSH terms: Estradiol; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Recurrent Urinary Tract Infection; Postmenopausal; Vaginal Estrogen

Summary:

      The investigators would like to know if the use of vaginally applied estrogen can prevent the
      problem of repeated urinary tract infections (UTI) in women who have gone through menopause.
      The investigators will use two forms of vaginal estrogen that are available by prescription
      (a ring and a cream) and compare their efficacy to that of a placebo (without any active
      ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs
      altogether and also the number of UTIs each group experiences over a 6 month period. After 6
      months, all subjects will receive vaginal estrogen and the women on the non-active treatment
      will be able to choose whether they would like to use either the estrogen ring or cream. The
      investigators will then be able to compare the number of UTIs on and off active vaginal
      estrogen treatment within those subjects who started on the placebo. The investigators are
      also going to look at quality of life before and during treatment using questionnaires and
      whether subjects stop using the treatments or do not use them as directed (compliance).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral
             salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal
             symptoms for >1 year OR age >55

          2. Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6
             months)- one UTI must be documented by culture, others may be documented by urinalysis

          3. Ability to provide informed consent

        Exclusion Criteria:

          1. Use of any investigational drug or device within thirty days of screening

          2. Urologic surgery within the past 3 months of screening or plan for surgery within one
             year of screening

          3. Diagnosis of Interstitial Cystitis/painful bladder syndrome

          4. History of urinary tract infections which require the use of IV antibiotics or where
             only one oral antibiotic is available for treatment, or where the risk of treatment
             with vaginal estrogen only is deemed unacceptable by the principle investigator
             secondary to the severity of prior urinary tract infections

          5. Known etiology of infection such as, but not limited to: kidney or bladder stones,
             enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization,
             indwelling catheter, poorly controlled diabetes

          6. Urothelial cancer

          7. Actively treated estrogen sensitive tumor (breast or endometrial cancer)

          8. Undiagnosed vaginal bleeding

          9. Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal
             length)

         10. Any medical reason the investigator deems incompatible with treatment with vaginal
             estrogen

         11. Prolapse requiring pessary use

        Deferral Criteria

          1. Undiagnosed hematuria - may enroll after malignancy is ruled out

          2. Use of a progestin containing intrauterine device or use of any vaginal androgens,
             estrogens or progestins within 3 months of enrollment - may enroll after wash out

          3. Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic
             antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after
             wash out if still meets inclusion criteria.

          4. History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval
             by the subject's primary oncologist or primary care physician