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

Last updated: December 26, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

Estradiol vaginal cream

Estradiol Vaginal Tablet

Clinical Study ID

NCT05723601
IRB00092892
  • Ages 20-80
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women age 20-80 who are post-menopausal or have undergone surgical menopause.Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause throughbilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with priorhysterectomy

  • New or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or moreUTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least oneculture documented UTI, the remaining can be documented by urinalysis showingnitrites and leukocyte esterase.

  • Not currently taking daily prophylactic antibiotics

  • Willing to use vaginal estrogen for prevention of recurrent UTIs

Exclusion

Exclusion Criteria:

  • Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinaryabnormalities, fistula, history of renal transplant or anatomic abnormality of thekidney

  • Fecal incontinence, intermittent catheterization or indwelling catheter, poorlycontrolled DM, urothelial cancer, estrogen-sensitive cancer including active breastcancer

  • Recent urologic surgery within 3 months

  • Inability to retain vaginal tablet (ex due to advanced prolapse, history ofcolpocleisis)

  • Other medical reasons that are deemed incompatible with vaginal estrogen treatment

  • Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1month wash-out period

  • Inability to follow up at clinic study site to give sample, for example due totransportation issues

  • Organ transplant patients

  • Patients on systemic hormone replacement therapy (HRT)

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Estradiol vaginal cream
Phase: 4
Study Start date:
January 12, 2024
Estimated Completion Date:
January 31, 2026

Study Description

This study is a cross-over randomized study to assess preference. Participants will be in the study for 6 months, they will use vaginal estradiol cream for 3 months and vaginal estradiol tablet for 3 months. Patients who meet diagnostic criteria for rUTI will be recruited. Group A participants will start with 3 months of cream and then switch to tablets. Group B will start with 3 months of tablets and switch to cream. In addition, participants may be started on other supplemental medications (Cranberry, D-mannose, methenamine) at the discretion of their provider. Patients will get monthly phone calls to assess for side effects, safety concerns, and symptoms of UTI.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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