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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the preferences of post-menopausal women with recurrent urinary tract infections (rUTIs) regarding two types of vaginal estrogen treatments: a tablet and a cream. Researchers want to find out which option women prefer, as vaginal estrogen has been shown to help reduce the number of rUTIs. Previous studies suggest that many women find it easier to use a tablet rather than a cream, which could lead to better treatment compliance and outcomes.

To participate in this trial, women aged 20 to 80 who are post-menopausal and have experienced rUTIs (three or more in the past year or two or more in the last six months) may be eligible. Participants should not currently be taking daily antibiotics for prevention and must be willing to use vaginal estrogen. Throughout the study, participants will use the assigned treatment and provide feedback on their experience. This trial is currently recruiting, and it aims to help improve treatment options for women suffering from recurrent urinary tract infections.

Gender

FEMALE

Eligibility criteria

• 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 through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomy
• • 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.
• • Not currently taking daily prophylactic antibiotics
• • Willing to use vaginal estrogen for prevention of recurrent UTIs
• Exclusion Criteria:
• • Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney
• • Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer
• • Recent urologic surgery within 3 months
• • Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis)
• • 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 1 month wash-out period
• • Inability to follow up at clinic study site to give sample, for example due to transportation issues
• • Organ transplant patients
• • Patients on systemic hormone replacement therapy (HRT)