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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472779
Other study ID # STUDY22010147
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 3, 2023
Est. completion date January 1, 2025

Study information

Verified date January 2024
Source University of Pittsburgh
Contact Stephanie W Zuo, MD
Phone 412-270-4818
Email zuos@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date January 1, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Postmenopausal (definition: No menses for 1 or more years or surgical menopause (bilateral oophorectomy). If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause) or have laboratory evidence of menopause (ie. FSH >30)) - Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6 months or 3 or more UTI in 1 year - May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study. - Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI Exclusion Criteria: - Current use of vaginal or oral estrogen products - Inability or refusal to use vaginal estrogen - Daily antibiotic use - Significant vaginal stenosis (eg. due to lichen sclerosis, radiation or obliterative prolapse surgery) that would prohibit use of a vaginal applicator (ie. genital hiatus <1cm) - Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis) - Frequent (1x weekly or more frequent) use of bladder instillations containing an antibiotic - Known hydronephrosis as a result of incomplete bladder emptying - Use of intermittent or indwelling urinary catheterization - Known bladder stones, mesh erosion into bladder, or foreign object in bladder - Unable to consent for self - Active treatment for an estrogen-dependent malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Periurethral application of estradiol cream
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.
Intravaginal application of estradiol cream
The control group will apply 1 gram estradiol cream intravaginally using an applicator.

Locations

Country Name City State
United States UPMC Lemieux Sports Complex Cranberry Township Pennsylvania
United States UPMC Hamot Erie Pennsylvania
United States University of Pittsburgh Medical Center-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC Passavant-McCandless Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Stephanie Wang Zuo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants who are UTI-free at 6 months 6 months
Secondary 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
Secondary Change from baseline in vaginal symptoms at 6 months Questionnaire assessment of vaginal symptoms and bother using 5-point Likert scale, developed by research team Baseline, 6 months
Secondary 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
Secondary Amount of estrogen cream used Estradiol cream tubes will be weighed at each research visit in grams 6 months
Secondary 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
Secondary Change from baseline in vaginal pH at 6 months Assessment using pH strips during pelvic examination Baseline, 6 months
Secondary 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
Secondary 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
Secondary 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
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