Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.
研究概览
简要总结
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections.
The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown.
The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.
详细描述
Background:
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections.
The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown.
The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •60-90 yo Female
- •Postmenopausal
- •Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
- •English Proficiency
- •Unable or unwilling to use topical estrogen.
- •Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
- •Patient on oral estrogen therapy may be included.
- •Patient with slings, prior vaginal surgery or pessary may be included.
排除标准
- •Current UTI/ Dipstick and culture positive (> trace leukocytes or nitrites)
- •Antibiotic (vaginal or oral) use in the last 4 weeks
- •Current sexually transmitted infection
- •Chronic Foley catheter use or chronic ureteral stent placement.
- •Vaginal probiotic use in the last 4 weeks
- •Patient currently using vaginal estrogen.
- •Post-void Residual Volume >150 mL or current diagnosis of urinary retention
- •Non-evaluated hematuria (> trace on dipstick, microscopic, gross)
- •Unable to complete study tasks or comply with follow up.
研究组 & 干预措施
Vaginal Placebo Cream Arm
Women enrolled in this arm will receive vaginal placebo cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.
干预措施: Vaginal Cream with Applicator (Drug)
Vaginal Testosterone Cream Arm
Women enrolled in this arm will receive vaginal testosterone cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.
干预措施: Vaginal Cream with Applicator (Drug)
结局指标
主要结局
To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.
时间窗: 9 months
Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 9 months to check for presence of UTI.
To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.
时间窗: 9 months
The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 9 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.
To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.
时间窗: 1 month
Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 1 month to check for presence of UTI.
To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.
时间窗: 4.5 months
Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 4.5 months to check for presence of UTI.
To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.
时间窗: 1 month
The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 1 month to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.
To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.
时间窗: 4.5 months
The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 4.5 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.
次要结局
未报告次要终点
研究者
Jefferson Drapkin
Research Manager
Maimonides Medical Center