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Due to rising antibiotic resistance, there has been a focus on non-antibiotic prophylactic measures for postmenopausal patients with recurrent urinary tract infections (rUTI), one of which is the safe and efficacious option of vaginal estrogen therapy. Standard application of vaginal estrogen cream entails intravaginal application of the cream twice a week, but some providers counsel patients with rUTI to apply a small, pea-sized amount to the periurethral area. This ideally reduces the amount of vaginal estrogen used while attaining a similar effect. However, to date, there is no data to prove that the periurethral technique of application is similar or non-inferior to intravaginal application in preventing UTI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravaginal Estrogen Application | Active Comparator | Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months |
|
| Periurethral Estrogen Application | Experimental | Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periurethral application of estradiol cream | Drug | The experimental group will apply estradiol cream in a different location (periurethral) and at a smaller dose (0.5 gram) compared to the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who are UTI-free at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urinary symptoms at 6 months | Questionnaire assessment of urinary symptoms and symptom distress (Urogenital Distress Inventory, Short Form), total score range 0-100 with higher numbers representing worse urinary symptoms | Baseline, 6 months |
| Change from baseline in vaginal symptoms at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie W Zuo, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Lemieux Sports Complex | Cranberry Township | Pennsylvania | 16066 | United States | ||
| UPMC Hamot |
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| Intravaginal application of estradiol cream | Drug | The control group will apply 1 gram estradiol cream intravaginally using an applicator. |
|
Questionnaire assessment of vaginal symptoms and bother using 5-point Likert scale, developed by research team |
| Baseline, 6 months |
| Change from baseline in sexual function at 6 months | Questionnaire assessment of sexual function (Female Sexual Function Index-6) with scores ranging from 2 to 30, with 19 and below denoting sexual dysfunction. | Baseline, 6 months |
| Amount of estrogen cream used | Estradiol cream tubes will be weighed at each research visit in grams | 6 months |
| Participant experience with use of estrogen cream | Questionnaire assessment of patient experience using 5-point Likert and open-ended questions, developed by the research team | 6 months |
| Change from baseline in vaginal pH at 6 months | Assessment using pH strips during pelvic examination | Baseline, 6 months |
| Change from baseline in vaginal maturation index at 6 months | Assessment of vaginal cell types using a superficial swab, collected from proximal vagina | Baseline, 6 months |
| Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months | Clean catch urine and vaginal swab sample collection with quantification of Lactobacillus | Baseline, 6 months |
| Change from baseline in Vaginal and urinary E. coli levels at 6 months | Clean catch urine and vaginal swab sample collection for quantification of E. coli | Baseline, 6 months |
| Erie |
| Pennsylvania |
| 16550 |
| United States |
| University of Pittsburgh Medical Center-Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Passavant-McCandless | Pittsburgh | Pennsylvania | 15237 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2026 | Jul 6, 2026 | 7 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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