Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections

Recurrent Urinary Tract Infection Clinical Trial

— TAPER  

Official title:

Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections: TAPER (Techniques of APplying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472779
• Other study ID #: STUDY22010147
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrence
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

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