Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Patient preference rate for vaginal estradiol cream versus tablet
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
cream used first and then switch to tablets
participants will start with 3 months of cream and then switch to tablets
干预措施: Estradiol vaginal cream (Drug)
cream used first and then switch to tablets
participants will start with 3 months of cream and then switch to tablets
干预措施: Estradiol Vaginal Tablet (Drug)
tablets used first and switch to cream
participants will start with 3 months of tablets and switch to cream
干预措施: Estradiol vaginal cream (Drug)
tablets used first and switch to cream
participants will start with 3 months of tablets and switch to cream
干预措施: Estradiol Vaginal Tablet (Drug)
结局指标
主要结局
Patient preference rate for vaginal estradiol cream versus tablet
时间窗: month 6
Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"
次要结局
- Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream(Baseline, Month 3, and Month 6)
- Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)(Month 3 and Month 6)
- Changes in adherence scores(Month 3 and Month 6)