Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections (TAPER)
Primary Purpose
Recurrent Urinary Tract Infection
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Periurethral application of estradiol cream
Intravaginal application of estradiol cream
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal (definition: No menses for 1 or more years. If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause))
- 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
- Unable to consent for self
- History of or at high risk for estrogen-dependent malignancy
Sites / Locations
- UPMC Lemieux Sports ComplexRecruiting
- UPMC HamotRecruiting
- University of Pittsburgh Medical Center-Magee Womens HospitalRecruiting
- UPMC Passavant-McCandlessRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intravaginal Estrogen Application
Periurethral Estrogen Application
Arm Description
Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months
Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months
Outcomes
Primary Outcome Measures
Time to urinary tract infection
Time to first urinary tract infection after initiation of study intervention
Secondary Outcome Measures
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
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
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.
Amount of estrogen cream used
Estradiol cream tubes will be weighed at each research visit in grams
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
Change from baseline in vaginal pH at 6 months
Assessment using pH strips during pelvic examination
Change from baseline in vaginal maturation index at 6 months
Assessment of vaginal cell types using a superficial swab, collected from proximal vagina
Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months
Clean catch urine and vaginal swab sample collection with quantification of Lactobacillus
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05472779
Brief Title
Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephanie Wang Zuo
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravaginal Estrogen Application
Arm Type
Active Comparator
Arm Description
Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months
Arm Title
Periurethral Estrogen Application
Arm Type
Experimental
Arm Description
Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months
Intervention Type
Drug
Intervention Name(s)
Periurethral application of estradiol cream
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravaginal application of estradiol cream
Intervention Description
The control group will apply 1 gram estradiol cream intravaginally using an applicator.
Primary Outcome Measure Information:
Title
Time to urinary tract infection
Description
Time to first urinary tract infection after initiation of study intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in urinary symptoms at 6 months
Description
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
Time Frame
Baseline, 6 months
Title
Change from baseline in vaginal symptoms at 6 months
Description
Questionnaire assessment of vaginal symptoms and bother using 5-point Likert scale, developed by research team
Time Frame
Baseline, 6 months
Title
Change from baseline in sexual function at 6 months
Description
Questionnaire assessment of sexual function (Female Sexual Function Index-6) with scores ranging from 2 to 30, with 19 and below denoting sexual dysfunction.
Time Frame
Baseline, 6 months
Title
Amount of estrogen cream used
Description
Estradiol cream tubes will be weighed at each research visit in grams
Time Frame
6 months
Title
Participant experience with use of estrogen cream
Description
Questionnaire assessment of patient experience using 5-point Likert and open-ended questions, developed by the research team
Time Frame
6 months
Title
Change from baseline in vaginal pH at 6 months
Description
Assessment using pH strips during pelvic examination
Time Frame
Baseline, 6 months
Title
Change from baseline in vaginal maturation index at 6 months
Description
Assessment of vaginal cell types using a superficial swab, collected from proximal vagina
Time Frame
Baseline, 6 months
Title
Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months
Description
Clean catch urine and vaginal swab sample collection with quantification of Lactobacillus
Time Frame
Baseline, 6 months
Title
Change from baseline in Vaginal and urinary E. coli levels at 6 months
Description
Clean catch urine and vaginal swab sample collection for quantification of E. coli
Time Frame
Baseline, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
History of or at high risk for estrogen-dependent malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie W Zuo, MD
Phone
412-270-4818
Email
zuos@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Baranski
Phone
412-641-7894
Email
baranskil@mail.magee.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie W Zuo, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Lemieux Sports Complex
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Baranski
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Paterniti
Facility Name
University of Pittsburgh Medical Center-Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Baranski
Facility Name
UPMC Passavant-McCandless
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Baranski
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections
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