Effect of Chlorhexidine Perineal Lavage Following Defecation in Post-Menopausal Women With Recurrent Urinary Tract Infection
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Rate of Urinary Tract Infection (UTI)
研究概览
简要总结
A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.
详细描述
There is a critical need for low-cost, non-antibiotic interventions that are feasible for patients to utilize for risk reduction and prevention of recurrent urinary tract infections (UTIs). The current most effective non-antibiotic prophylaxis for recurrent UTI is vaginal estrogen; however, approximately 50% of women will continue to experience UTIs. The investigators propose a randomized control trial of postmenopausal women on vaginal estrogen with the diagnosis of recurrent UTIs to evaluate a novel post-defecation hygienic strategy utilizing a 2% chlorhexidine perineal lavage. Participants will be randomized to either a 2% chlorhexidine perineal lavage or a water lavage. Study participants will be followed for up to 6-months, and UTIs will be tracked with culture proven samples throughout study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their assigned treatment. All participants will receive a box containing their randomized intervention and identical use instructions. Opaque bottles will contain either a sterile water solution or 2% chlorhexidine. Spray bottles will be identical in external appearance.
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal female between age 55 and 89
- •No post-menopausal bleeding
- •Diagnosis of recurrent urinary tract infection (UTI) in the electronic health record or as two culture proven UTIs in 6 months or three culture proven UTIs in 12 months
- •At least one UTI in the 6 months prior to entering the study
- •Asymptomatic for UTI symptoms at the time of enrollment.
- •On vaginal estrogen therapy for at least 6 weeks prior to enrollment
- •Ready access to email and internet
排除标准
- •Recent prophylactic antibiotic use (washout period of 4 weeks)
- •Neurogenic bladder
- •Diagnosis of urinary retention
- •Uncorrected Stage III-IV prolapse
- •Indwelling catheter or need for intermittent self-catheterization
- •History of complicated UTIs
- •History of interstitial cystitis or bladder pain syndrome
- •History of fecal incontinence/accidental bowel leakage
- •Greater than 14 bowel movements per week
- •Non-English speaking
- •Allergy to chlorhexidine gluconate
- •Inability to utilize vaginal estrogen therapy
- •Recent urogynecological or urologic surgery (<12 weeks)
研究组 & 干预措施
Chlorhexidine Lavage
2% chlorhexidine perineal lavage following defecation
干预措施: Chlorhexidine (Drug)
Sterile Water Lavage
Sterile water perineal lavage following defecation
干预措施: Sterile Water (Drug)
结局指标
主要结局
Rate of Urinary Tract Infection (UTI)
时间窗: 90 days following treatment initiation
The proportion of participants in each arm who experience a urinary tract infection (UTI) within 90 days will be compared
次要结局
- Vulvovaginal Symptom Questionnaire (VSQ)(VSQ administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization)
- Urinary Distress Inventory (UDI-6)(UDI-6 administered prior to randomization and at 6 weeks, 12 weeks, and 24 weeks post-randomization)
研究者
Sara Cichowski
Principal Investigator
Oregon Health and Science University