NCT01123135撤回不适用
The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the effects of vaginal estrogen replacement versus placebo on the subjective improvement of stress urinary incontinence symptoms with the use of validated questionnaires.
研究概览
简要总结
This is a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo.
详细描述
- This will be a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo. Study subjects will be patients diagnosed with stress urinary incontinence by urodynamic evaluation. They will have filled out the IIQ-7 and UDI-6 validated questionnaires as is routine for all patients being evaluated for stress incontinence. After enrollment and informed consent, their initial screening will include a Pap smear for vaginal maturation.
- Subjects will then be seen at 4, 8 and 12 weeks. At each visit, they will turn in their medication tubes and receive new study medication. They will also be screened for any adverse reaction to the study medication at each visit.
- At the end of the study period, the subjects will fill out the same validated questionnaire as they did at the beginning of the study and they will also have their urethral pressure profile and PAP smear repeated.
- The urethral pressure profile is part of the standard complex urodynamic testing that all patients undergo for evaluation and diagnosis of urodynamic stress incontinence. Urethral Pressure Profile is a technique used to provide information about the ability of the urethra to prevent leakage. The Urethral Pressure Profile is a specific study, in which a special design catheter is pulled through the urethra at a slow, continuous rate. The resulting "bell shaped" curve illustrates the function of the urethra from the beginning of the bladder neck out through the meatus.
- The placebo cream will be a pharmacologically inert formulation which will be packaged similarly to the active premarin cream and visually indistinguishable from the active drug to both the study subjects and researchers.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Postmenopausal women (No menses for a minimum period of 1 year)
- •Urodynamic stress urinary incontinence
排除标准
- •History of breast or uterine cancer
- •History of venous thrombolic event
- •Hormone replacement therapy within 3 months of study
- •Sensitivity or allergy to premarin cream
- •Current use of any medications for urge or stress incontinence
- •Prior surgery for stress incontinence
- •Overactive bladder or Detrussor instability
- •Active vaginal/ bladder infection (patients will be treated and have a negative test for cure in order to be enrolled in the study)
- •History of pelvic or vaginal radiation therapy
研究组 & 干预措施
Vaginal ERT
Active Comparator
Vaginal ERT cream 1 gm at bed time 3 times a week
干预措施: Vaginal ERT (Drug)
Placebo
Placebo Comparator
1gm of placebo at bed time 3 times a week
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effects of vaginal estrogen replacement versus placebo on the subjective improvement of stress urinary incontinence symptoms with the use of validated questionnaires.
时间窗: Exam at baseline and 12 weeks
次要结局
- Determine effects of vaginal ERT vs placebo on objective improvement in urethral function by comparing pre and post treatment urethral closure pressures. Determine incidence of UTIs at the beginning of study compared to the end of the study.(Exam at baseline and 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
3VM for Treatment of Chronic Osteoarthritis Knee PainArthritis, DegenerativeNCT03142178CDA Research Group, Inc.150
已完成
不适用
Study of Long-Term Antibiotic Treatment in Reactive ArthritisReactive ArthritisNCT00621387University of Helsinki56
已完成
3 期
Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal FissuresChronic Anal FissuresNCT01690221Ventrus Biosciences, Inc434
已完成
1 期
Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy SubjectsHealthyNCT02551497Biogen36
Unknown
3 期
The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19COVID-19NCT04659239Chinese Academy of Medical Sciences34,020