Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women: A Randomized Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Storage symptom improvement
研究概览
简要总结
The goal of this clinical trial is to evaluate whether vaginal 17β-estradiol effectively treats storage symptoms of lower urinary tract symptoms (LUTS) and enhances quality of life. The main questions it aims to answer are:
- What is the efficacy of vaginal 17β-estradiol treatment compared to placebo in alleviating storage symptoms of LUTS?
- How does vaginal 17β-estradiol treatment affect the urethral maturation index and vaginal pH compared to placebo?
- What impact does vaginal 17β-estradiol treatment have on overall quality of life and patients' perception of global improvement (PGI)?
Participants in the trial will undergo the following procedures:
- Screening procedures at the first visit to exclude correctable causes of LUTS and to complete a bladder diary.
- Visit the clinic at 1-2 weeks for a review of the bladder diary and a check-up. Participants will receive the assigned dosage of vaginal 17β-estradiol or placebo: one vaginal tablet daily for two weeks, followed by one vaginal tablet twice a week for 10 weeks.
- The third and fourth visits (at 4 and 12 weeks after treatment) will involve: completion of bladder diaries, questionnaires, vaginal pH testing, collection of urethral maturation index (UMI), observation of intervention's side effects and monitoring of LUTS symptoms.
详细描述
I. First Visit and Recruitment
Participants will be recruited from the urogynecology clinic, menopause clinic, and urology clinic using hospital and public advertisement. An information sheet in Thai language will be provided to health care providers in the designated outpatient department (OPD) which can ensure the providers convey the correct study information to potential participant. Participants will only be able to enroll into this study one time.
Informed Consent
Individuals with at least one storage symptom of LUTS presenting to clinics in selected OPD will undergo the informed consent process by principal investigator prior to initiating screening procedures. Consent form in Thai language describing in detail the study procedures will be given to the participant privately in a separate room, and extensive discussion of risks and possible benefits of participation in this study will be provided. Participation will be informed that they may withdraw consent at any time throughout the course of this study.
Screening
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presenting with storage phase symptom score more than/equal to 1 evaluated by the ICIQ-FLUTS questionnaire in these items
- •Item 2a) nocturia and/or
- •Item 3a) urgency and/or
- •Item 5a) daytime frequency and/or
- •Item 9a) UUI and/or
- •Item 11a) SUI
- •Being natural or surgical menopause for more than 1 year
- •Absence of urinary tract infection or other identifiable cause
- •Not using hormone replacement therapy or any route of estrogen within 4 weeks
- •Never undergone onabotulinumtoxinA therapy, percutaneous tibial nerve stimulation (PTNS), or neuromodulation for overactive bladder (OAB) treatment
- •Willing to adhere to the research protocol and actively participate in the scheduled follow-up appointments as delineated within the framework of this study
排除标准
- •Contraindication for estrogen therapy: undiagnosed abnormal vaginal bleeding, previous thromboembolic event, breast cancer, gynecologic/genitourinary malignancy, active liver disease
- •Pelvic organ prolapse of anterior compartment stage III and IV
- •Immunocompromised patient or taking immunosuppressant drug
- •History of antibiotics drug use within the past 7 days
- •History of bladder outlet obstruction
- •History of using anti-muscarinics, beta3-adrenoceptor agonists, vaginal energy-based devices (laser and radiofrequency) or electromagnetic energy-based therapies within the past 2 weeks
- •History of documented positive urine culture in the past 6 weeks
- •Have an allergic reaction to study's drug
- •Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
研究组 & 干预措施
Group A: Behavioral modifications and vaginal 17beta-estradiol
• 17beta-Estradiol 10 mcg + Behavioral modifications
干预措施: vaginal 17 beta-estradiol (Drug)
Group A: Behavioral modifications and vaginal 17beta-estradiol
• 17beta-Estradiol 10 mcg + Behavioral modifications
干预措施: Behavioral modifications (Behavioral)
Group B: Behavioral modifications + Placebo
• Placebo + Behavioral modifications
干预措施: Placebo (Drug)
Group B: Behavioral modifications + Placebo
• Placebo + Behavioral modifications
干预措施: Behavioral modifications (Behavioral)
结局指标
主要结局
Storage symptom improvement
时间窗: The patients were monitored closely for 1 and 3 months after treatment.
Storage Symptom Improvement: This will be evaluated using the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), validated in Thai. The questionnaire includes 5 items addressing storage symptoms: * 2a) Nocturia * 3a) Urgency * 5a) Daytime frequency * 9a) Urgency urinary incontinence (UUI) * 11a) Stress urinary incontinence (SUI) Each severity item is rated from 0 to 4, and each bothersome item from 0 to 10. The total severity score ranges from 0 to 20, and the total bothersome score ranges from 0 to 50. Higher scores indicate worse outcomes. Outcome Interpretation: * Improved: Mean ICIQ-FLUTS post-treatment score \< pre-treatment score. * Not Improved: Mean ICIQ-FLUTS post-treatment score ≥ pre-treatment score.
次要结局
- The impact of urinary storage symptoms on quality of life(The patients were monitored closely for 1 and 3 months after treatment.)
- Global Improvement score(The patients were monitored closely for 1 and 3 months after treatment.)
- Urethral maturation index (UMI) and maturation value (MV)(The patients were monitored closely for 1 and 3 months after treatment.)
- Vaginal pH(The patients were monitored closely for 1 and 3 months after treatment.)