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

Status:	Completed
Conditions:	Infectious Disease, Urology
Therapuetic Areas:	Immunology / Infectious Diseases, Nephrology / Urology
Healthy:	No
Age Range:	18 - 100
Updated:	12/31/2017
Start Date:	October 2013
End Date:	December 2017

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 randomized to 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).

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

We found this trial at

sites

New York University Langone Medical Center

550 1st Ave
New York, New York 10016

(212) 263-7300