Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 4

Conditions: Recurrent Urinary Tract Infection

Treatments: Drug: Estradiol Vaginal Tablet; Drug: Estradiol vaginal cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05723601

IRB00092892

Details and patient eligibility

About

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.

Full description

This study is a cross-over randomized study to assess preference. Participants will be in the study for 6 months, they will use vaginal estradiol cream for 3 months and vaginal estradiol tablet for 3 months. Patients who meet diagnostic criteria for rUTI will be recruited. Group A participants will start with 3 months of cream and then switch to tablets. Group B will start with 3 months of tablets and switch to cream. In addition, participants may be started on other supplemental medications (Cranberry, D-mannose, methenamine) at the discretion of their provider. Patients will get monthly phone calls to assess for side effects, safety concerns, and symptoms of UTI.

Enrollment: 24 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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 hysterectomy
• New 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 antibiotics
• Willing to use vaginal estrogen for prevention of recurrent UTIs

Exclusion criteria

• Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney
• Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer
• Recent urologic surgery within 3 months
• Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis)
• Other medical reasons that are deemed incompatible with vaginal estrogen treatment
• Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period
• Inability to follow up at clinic study site to give sample, for example due to transportation issues
• Organ transplant patients
• Patients on systemic hormone replacement therapy (HRT)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

cream used first and then switch to tablets

Active Comparator group

Description:

participants will start with 3 months of cream and then switch to tablets

Treatment:

Drug: Estradiol vaginal cream

Drug: Estradiol Vaginal Tablet

tablets used first and switch to cream

Active Comparator group

Description:

participants will start with 3 months of tablets and switch to cream

Treatment:

Drug: Estradiol vaginal cream

Drug: Estradiol Vaginal Tablet