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NCT05723601
Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream
Conditions: Recurrent Urinary Tract Infection
Sex: Female
Ages: 20 Years – 80 Years
Phase: PHASE4
Enrollment: 24
Sponsor: Wake Forest University Health Sciences
Location: United States
Summary
Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women.
However, prior studies have shown the compliance rate for topical estrogen cream is low.
The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance.
There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.
Eligibility Criteria
Inclusion Criteria:Women age 20-80 who are post-menopausal or have undergone surgical menopause.
Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomyNew or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or more UTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least one culture documented UTI, the remaining can be documented by urinalysis showing nitrites and leukocyte esterase.Not currently taking daily prophylactic antibioticsWilling to use vaginal estrogen for prevention of recurrent UTIsExclusion Criteria:Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidneyFecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancerRecent urologic surgery within 3 monthsInability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis)Other medical reasons that are deemed incompatible with vaginal estrogen treatmentUse of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out periodInability to follow up at clinic study site to give sample, for example due to transportation issuesOrgan transplant patientsPatients on systemic hormone replacement therapy (HRT)
Source: ClinicalTrials.gov (NCT05723601). StuddyBuddy aggregates publicly available trial information.