Preference of vaginal estradiol tablet versus cream for recurrent urinary tract infections in women
Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
This study is testing whether post-menopausal women prefer using vaginal estradiol tablets or cream to help with their recurrent urinary tract infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05723601 on ClinicalTrials.gov |
What this trial studies
This study evaluates the preference of post-menopausal women with recurrent urinary tract infections (rUTI) for vaginal estradiol tablets compared to vaginal estradiol cream. It is a cross-over randomized study where participants will use each form of estradiol for three months, with a total study duration of six months. Participants will be monitored through monthly phone calls to assess side effects, safety, and UTI symptoms. The goal is to determine which form of treatment is preferred and potentially improve compliance in managing rUTI.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women aged 20-80 with a history of recurrent urinary tract infections.
Not a fit: Patients with interstitial cystitis, bladder pain syndrome, or those currently taking daily prophylactic antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment adherence and reduce the incidence of recurrent urinary tract infections in post-menopausal women.
How similar studies have performed: Previous studies have shown that vaginal estradiol tablets improve compliance in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Candace Parker-Autry, MD — Wake Forest University Health Sciences
- Study coordinator: Martina Gabra, MD
- Email: mgabra@wakehealth.edu
- Phone: 336-713-4098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.