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

Phase 4

Recruiting

• Conditions: Recurrent Urinary Tract Infection
• Interventions: Drug: Estradiol vaginal cream; Drug: Estradiol Vaginal Tablet

• Registration Number: NCT05723601
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Study Start: 2024-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tablets used first and switch to cream	Estradiol vaginal cream	participants will start with 3 months of tablets and switch to cream
tablets used first and switch to cream	Estradiol Vaginal Tablet	participants will start with 3 months of tablets and switch to cream
cream used first and then switch to tablets	Estradiol vaginal cream	participants will start with 3 months of cream and then switch to tablets
cream used first and then switch to tablets	Estradiol Vaginal Tablet	participants will start with 3 months of cream and then switch to tablets

Primary Outcome Measures

Name	Time	Method
Patient preference rate for vaginal estradiol cream versus tablet	month 6	Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"

Secondary Outcome Measures

Name	Time	Method
Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream	Baseline, Month 3, and Month 6	Vaginal culture swab and urine culture specimens will be collected - The specimens will be sent for species-specific polymerase chain reaction (PCR) for Lactobacillus
Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)	Month 3 and Month 6	Treatment Satisfaction Questionnaire for Medication (TSQM) - The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. A questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration.
Changes in adherence scores	Month 3 and Month 6	Adherence will be assessed by the medication adherence questionnaire (MAQ) - The MAQ will be used to determine medication adherence. This questionnaire asks respondents about past experience in taking medications. The responses are 'yes' or 'no' and are scored as yes=1 and no=0. Scores will be summed: high adherence = score of 0 points; medium adherence = score of 1-2 points, and low adherence = score of 3-4 points. Means and standard deviations will be compared within and between groups.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States