Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: American Urogynecologic Society; New York University Langone Medical Center; NYU Langone Health
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Estrogens, Conjugated (USP); Polyestradiol phosphate

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