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

December 1, 2025 updated by: Wake Forest University Health Sciences

Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cream used first and then switch to tablets
participants will start with 3 months of cream and then switch to tablets
Drug: Estradiol vaginal cream
Participants will use vaginal estradiol cream for 3 months
Drug: Estradiol Vaginal Tablet
Participants will use vaginal estradiol tablet for 3 months
Active Comparator: tablets used first and switch to cream
participants will start with 3 months of tablets and switch to cream
Drug: Estradiol vaginal cream
Participants will use vaginal estradiol cream for 3 months
Drug: Estradiol Vaginal Tablet
Participants will use vaginal estradiol tablet for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preference rate for vaginal estradiol cream versus tablet
Time Frame: 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?"
month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream
Time Frame: 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
Baseline, Month 3, and Month 6
Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: 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.
Month 3 and Month 6
Changes in adherence scores
Time Frame: 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.
Month 3 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Candace Parker-Autry, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00092892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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