RECRUITING

Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance. There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.

Official Title

Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial

Quick Facts

Study Start:2024-01-12
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05723601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women age 20-80 who are post-menopausal or have undergone surgical menopause. Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomy
  2. * New or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or more UTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least one culture documented UTI, the remaining can be documented by urinalysis showing nitrites and leukocyte esterase.
  3. * Not currently taking daily prophylactic antibiotics
  4. * Willing to use vaginal estrogen for prevention of recurrent UTIs
  1. * Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney
  2. * Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer
  3. * Recent urologic surgery within 3 months
  4. * Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis)
  5. * Other medical reasons that are deemed incompatible with vaginal estrogen treatment
  6. * Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period
  7. * Inability to follow up at clinic study site to give sample, for example due to transportation issues
  8. * Organ transplant patients
  9. * Patients on systemic hormone replacement therapy (HRT)

Contacts and Locations

Study Contact

Martina Gabra, MD
CONTACT
336-713-4098
mgabra@wakehealth.edu
Sachin Vyas, PhD
CONTACT
336-713-4098
svyas@wakehealth.edu

Principal Investigator

Candace Parker-Autry, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Candace Parker-Autry, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2025-01

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • vaginal estradiol cream
  • vaginal estradiol tablet

Additional Relevant MeSH Terms

  • Recurrent Urinary Tract Infection