Vaginal Estradiol Cream and Tablet for Recurrent UTI Prevention in Post-menopausal Women
This study aims to evaluate the preference between vaginal estradiol cream and tablet for preventing recurrent urinary tract infections in post-menopausal women.
Estradiol vaginal cream
+ Estradiol Vaginal Tablet
Urogenital Diseases+4
+ Female Urogenital Diseases and Pregnancy Complications
+ Infections
Prevention Study
Summary
Study start date: January 12, 2024
Actual date on which the first participant was enrolled.This study focuses on preventing recurring urinary tract infections (rUTIs) in post-menopausal women. It aims to find out whether women prefer using vaginal estradiol cream or vaginal estradiol tablets. This is important because recurring UTIs can be uncomfortable and challenging to manage, especially for women who have gone through menopause. Understanding preferences for treatment options can help doctors provide better, more personalized care to reduce the occurrence of these infections. Participants in the study will try both forms of treatment over six months. One group will use the cream for three months and then switch to the tablets, while the other group will do the opposite. Throughout the study, participants might also use other supplements like cranberry or D-mannose, depending on their doctor's advice. They will receive monthly phone calls to check for any side effects, safety issues, or UTI symptoms. At the end of six months, or if they choose to leave the study early, participants will be asked which form of treatment they prefer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Wake Forest University Health Sciences
Winston-Salem, United StatesOpen Wake Forest University Health Sciences in Google Maps