NCT06353269进行中（未招募）4 期
Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Adherence to vaginal estrogen treatment
研究概览
简要总结
- The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed.
- Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound.
- A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina.
Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.
- The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.
- There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.
If a participant is part of the microbiome cohort, they will also be asked to do the following:
- a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.
- Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.
- These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female, at least 18 years old with diagnosis of hypoestrogenism (defined by post-menopausal status of 12 months or more of amenorrhea, history of bilateral salpingo-oophorectomy) AND recurrent UTI as defined by greater than or equal to 3 in 1 year or 2 in 6 months by positive urine culture or clinically suspected UTI)
排除标准
- •Have a known etiology of infections (urologic stones, fistulas, fecal incontinence, catheterization, or poorly controlled diabetes - Hgb A1C cutoff of 8)
- •Contraindication to vaginal estrogen (actively treated estrogen-sensitive tumor, allergies to medication formulation, inability to apply or place vaginal estrogen of any modality)
- •Suspected mesh complications or voiding problems from pelvic reconstructive surgery
- •Short vaginal length (less than 7cm) or poor dexterity or mobility that may prevent use of estrogen ring
- •Do not speak English
- •For the nested cohort only - patients currently using vaginal estrogen greater than 2x per month
- •Deferral criteria:
- •Undiagnosed hematuria or vaginal bleeding; however enrollment may proceed after negative workup for malignancy
- •Remote history of estrogen-sensitive tumor: enrollment allowed after approval by oncologist or primary care physician
研究组 & 干预措施
Estrogen cream
Experimental
Participants in this arm will receive the vaginal estrogen cream (Estrace 0.01%) for treatment. Participants will apply 0.5gm twice per week for the duration of the study.
干预措施: Estrace 0.01% Vaginal Cream (Drug)
Estrogen drug-eluting ring
Experimental
Participants in this arm will receive the vaginal estrogen drug-eluting ring (Estring) for treatment. Participants will have the ring placed by a provider at their clinical visit. The ring will be exchanged every 12 weeks.
干预措施: Estring Vaginal Product (Drug)
Estrogen tablet
Experimental
Participants in this arm will receive the vaginal estrogen tablets (Vagifem) for treatment. Participants will place one tablet (10 mcg) into the vagina twice per week for the duration of the study.
干预措施: Vagifem (Drug)
结局指标
主要结局
Adherence to vaginal estrogen treatment
时间窗: 6 month follow-up visit
The primary outcome will be the adherence to vaginal estrogen treatment at the 6 month follow-up visit. The 6 month follow-up visit will be the endpoint of the study. The investigators will consider both subjective, patient-reported adherence at 6 months, as well as objective data - tube weight for the estrogen cream, number of tablets left for the estrogen tables, and presence or absence of drug-eluting ring on physical exam for the estrogen ring.
次要结局
- UTI rates(the 6 month duration of the study)
- validated patient questionnaires - Medication Adherence Report Scale (MARS-5)(Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up)
- Urologic microbiome results for nested microbiome cohort(baseline and 6 month follow-up visits)
- validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q)(Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up)
- Vaginal health index for nested microbiome cohort(baseline and 6 month follow-up visits)
- validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA)(Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up)
- optical coherence tomography measurements for nested OCT cohort - blood vessel density(baseline and 6 month follow-up visits)
- Vaginal maturation index for nested microbiome cohort(baseline and 6 month follow-up visits)
- validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6)(Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up)
- validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I)(Questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up)
- optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness(baseline and 6 month follow-up visits)
- Vaginal microbiome results for nested microbiome cohort(baseline and 6 month follow-up visits)
研究者
Charlotte Ter Haar
Resident Physician
University of California, Irvine
研究点 (2)
Loading locations...
相似试验
撤回
4 期
Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive SurgeryEstrogenPelvic Floor DisordersSurgeryMenopauseNCT02860897University Hospitals Cleveland Medical Center
已完成
3 期
Estrogen Treatment (Oral vs. Patches) in Turner SyndromeHypogonadismPremature Ovarian FailureTurner SyndromeNCT00140998Nemours Children's Clinic16
撤回
2 期
Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I DisorderBipolar 1 DisorderNervous System DiseasesSchizophreniaMental DisorderNCT01981811Otsuka Pharmaceutical Development & Commercialization, Inc.
已完成
不适用
Adherence to Antimalarial Drugs in Sierra LeoneMalariaNCT01967472London School of Hygiene and Tropical Medicine1,145
已完成
不适用
A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents With HIV and Their MothersAcquired Immunodeficiency SyndromeHIV InfectionsNCT00001699National Cancer Institute (NCI)45