Clinical Trials Logo

Clinical Trial Summary

- The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed. - Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound. - A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina. Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring. - The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires. - There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed. If a participant is part of the microbiome cohort, they will also be asked to do the following: - a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear. - Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall. - These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06353269
Study type Interventional
Source University of California, Irvine
Contact CHARLOTTE TER HAAR, MD
Phone 714-506-6351
Email terhaarc@hs.uci.edu
Status Recruiting
Phase Phase 4
Start date April 2024
Completion date October 2027

See also
  Status Clinical Trial Phase
Completed NCT02357758 - Effects of Antibiotic Prophylaxis on Recurrent UTI in Children Phase 4
Completed NCT04306731 - Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections. N/A
Recruiting NCT05553652 - The Effect of ASTARTEā„¢ on Recurrent Urinary Tract Infection N/A
Completed NCT01958073 - Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Phase 4
Recruiting NCT05652374 - Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study Phase 4
Recruiting NCT06124820 - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections N/A
Recruiting NCT04807894 - Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo Phase 4
Enrolling by invitation NCT04077580 - The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI Phase 4
Terminated NCT03143920 - Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder Early Phase 1
Recruiting NCT04859621 - Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections Phase 2
Terminated NCT04831840 - Recurrent Urinary Tract Infections and the Microbiome
Withdrawn NCT03854396 - Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women Phase 3
Completed NCT02705495 - Acupuncture for Prevention of Recurrent Urinary Tract Infections. N/A
Active, not recruiting NCT05537519 - Phage Therapy for the Treatment of Urinary Tract Infection Phase 1/Phase 2
Recruiting NCT06035601 - EHR-integrated rUTI Texting Platform N/A
Not yet recruiting NCT04285320 - Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections Phase 4
Recruiting NCT03142295 - Controlled Human Urine Transfusion for UTI N/A
Recruiting NCT05895578 - Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection. N/A
Completed NCT00214045 - Rigid Versus Flexible Cystoscopy in Women N/A
Enrolling by invitation NCT05551949 - Preventing Recurrent UTI With Vaginal Estrogen Phase 4