Clinical trial NCT05723601: Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream
Official title: Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Recurrent Urinary Tract Infection
Keywords: vaginal estradiol cream
vaginal estradiol tablet
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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 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)

Primary outcomes:
measure: Patient preference rate for vaginal estradiol cream versus tablet
timeFrame: month 6
Secondary outcomes:
measure: Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream
timeFrame: Baseline, Month 3, and Month 6
measure: Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Month 3 and Month 6
measure: Changes in adherence scores
timeFrame: Month 3 and Month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Candace Parker-Autry, MD
role: PRINCIPAL_INVESTIGATOR
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