Recurrent Urinary Tract InfectionPhase 2TAPERNCT05472779
Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections
A Phase 2 study testing Periurethral application of estradiol cream and Intravaginal application of estradiol cream in people with Recurrent Urinary Tract Infection, run by Stephanie Wang Zuo at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Periurethral application of estradiol cream and Intravaginal application of estradiol cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jan 2023to 25 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UPMC Lemieux Sports Complex
Cranberry Township, Pennsylvania, 16066
UPMC Hamot
Erie, Pennsylvania, 16550
University of Pittsburgh Medical Center-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Passavant-McCandless
Pittsburgh, Pennsylvania, 15237
About this study
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
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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Periurethral application of estradiol cream, Intravaginal application of estradiol cream
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periurethral application of estradiol creamDrug
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 creamDrug
The control group will apply 1 gram estradiol cream intravaginally using an applicator.
| Study group | Role | What they receive |
|---|---|---|
| Intravaginal Estrogen Application | Active comparator | Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months Receives: Drug: Intravaginal application of estradiol cream |
| Periurethral Estrogen Application | Experimental | Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months Receives: Drug: Periurethral application of estradiol cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are UTI-free at 6 Months
The primary outcome was the percentage of participants who were UTI-free at 6 months after study drug initiation.
Measured: 6 months
Secondary outcomes (8)
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
Measured: 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.
Measured: Baseline, 6 months
Change From Baseline in Vaginal pH at 6 Months
Assessment using pH strips during pelvic examination
Measured: Baseline, 6 months
Participant Experience With Study Drug
Agreement with the statement: "I am satisfied with the estrogen cream." (Positive response of "agree" or "strongly agree" on 5-point Likert Scale)
Measured: 6 months
Vaginal Maturation Value
Vaginal maturation value at 3 months (score 0-100, higher values correlating with greater vaginal estrogenization)
Measured: 3 months
Average Amount of Estrogen Used Per Tube
Study drug tubes were weighed at baseline and then at follow-up visits (weight in grams) and the average amount of study drug used per tube was calculated.
Measured: 6 months
Percentage of Participants With Lactobacillus Crispatus Positive Vaginal Specimens
Lactobacillus crispatus is a species of Lactobacillus known to assist with UTI prevention through the maintenance of an acidic environment. It generally is elevated in the vagina in the presence of estrogen.
Measured: 6 months
Percentage of Participants With E. Coli Positive Vaginal Specimens
- coli is a common uropathogen and thus was investigated in the pilot translational sub-aim of this research study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start3 Jan 2023
- Primary completion15 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Wang Zuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie Wang Zuo, University of Pittsburgh
- Investigators
- Stephanie W Zuo, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472779
- Sponsor's protocol ID
- STUDY22010147
- Acronym
- TAPER
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2022
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuo SW, Bradley M, Mowers EE, Zyczynski HM, Hillier SL, Ackenbom MF. Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial. Contemp Clin Trials. 2025 Jun;153:107893. doi: 10.1016/j.cct.2025.107893. Epub 2025 Mar 30.
PubMed 40169076Zuo SW, Mowers EE, Hem S, Bradley M, Zyczynski HM, Hillier SL, Ackenbom MF. Vaginal Estrogen Application Techniques for Prevention of Urinary Tract Infection: A Randomized Trial. Obstet Gynecol. 2026 Jul 27. doi: 10.1097/AOG.0000000000006376. Online ahead of print.
PubMed 42492951
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05472779
- Acronym / sponsor ID
- TAPER / STUDY22010147
- Conditions
- Recurrent Urinary Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Stephanie Wang ZuoUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravaginal Estrogen Application | Active comparator | Drug: Intravaginal application of estradiol creamIntravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months |
| Periurethral Estrogen Application | Experimental | Drug: Periurethral application of estradiol creamPeriurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periurethral application of estradiol creamThe experimental group will apply estradiol cream in a different location (periurethral) and at a smaller dose (0.5 gram) compared to the control group. | Drug | Periurethral Estrogen Application |
| Intravaginal application of estradiol creamThe control group will apply 1 gram estradiol cream intravaginally using an applicator. | Drug | Intravaginal Estrogen Application |
Primary outcome
Percentage of Participants Who Are UTI-free at 6 Months
Time frame: 6 months
The primary outcome was the percentage of participants who were UTI-free at 6 months after study drug initiation.
8 secondary outcomes
Change From Baseline in Urinary Symptoms at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Sexual Function at 6 Months
Time frame: Baseline, 6 months
Change From Baseline in Vaginal pH at 6 Months
Time frame: Baseline, 6 months
Participant Experience With Study Drug
Time frame: 6 months
Vaginal Maturation Value
Time frame: 3 months
Average Amount of Estrogen Used Per Tube
Time frame: 6 months
Percentage of Participants With Lactobacillus Crispatus Positive Vaginal Specimens
Time frame: 6 months
Percentage of Participants With E. Coli Positive Vaginal Specimens
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40169076Zuo SW, Bradley M, Mowers EE, Zyczynski HM, Hillier SL, Ackenbom MF. Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial. Contemp Clin Trials. 2025 Jun;153:107893. doi: 10.1016/j.cct.2025.107893. Epub 2025 Mar 30.
- Results publication: PubMed 42492951Zuo SW, Mowers EE, Hem S, Bradley M, Zyczynski HM, Hillier SL, Ackenbom MF. Vaginal Estrogen Application Techniques for Prevention of Urinary Tract Infection: A Randomized Trial. Obstet Gynecol. 2026 Jul 27. doi: 10.1097/AOG.0000000000006376. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Recurrent Urinary Tract Infection
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie W Zuo, MD principal investigator
University of Pittsburgh Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Periurethral application of estradiol cream and Intravaginal application of estradiol cream in people with Recurrent Urinary Tract Infection, run by Stephanie Wang Zuo at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Are UTI-free at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472779, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.