PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Adapted International Prostate Symptom Score (IPSS)
研究概览
简要总结
This is a pilot 12-week randomized, placebo-controlled N-of-1 deprescribing trial among older men receiving chronic tamsulosin therapy for lower urinary tract symptoms attributed to benign prostatic hyperplasia.
详细描述
The investigators will instruct participants to monitor and record their daily urinary symptoms and medication side effects through Redcap surveys, accessible via smartphone. Medication adherence, global urinary satisfaction questions, and health-related quality of life will be assessed as baseline and at the end of the study.
Monitoring frequency: Participants will monitor their symptoms every day using the PERSONAL-pilot study Redcap surveys. If the investigators notice a subject has been unresponsive to daily symptom monitoring, the investigators will reach out to the subject and offer any help we can provide. The investigators first attempt will be in the form of an email, sent to the email address provided to send patients the surveys. If the investigators do not receive a response, the investigators will follow up with a phone call to offer any help or guidance. Email template and telephone script provided in other study documents of the application.
N-of-1 Trial Procedures:
Participants will start with a 1-week open label period where participants will use the PERSONAL Redcap surveys to track daily symptoms and side effects while not taking their tamsulosin or any study pills. Based on the pharmacokinetics and expected timeframe of symptomatic relief from tamsulosin (half-life=14 to 15 hours; steady state by the 5th day of daily dosing), all N-of-1 trials will have a duration of 11 weeks during which participants will complete 2 cycles consisting of a pair of 2-week treatment periods (taking tamsulosin or placebo) separated by 1 week of wash-out on placebo. The order of treatment periods within a cycle will be random (e.g. ABAB, BABA, ABBA, or BAAB) according to pre-filled bubble packs given to participants during their orientation visit.
Participants will receive a placebo during wash-out periods between treatment periods and cycles, but the participants will be unaware of the order or duration of treatment periods or cycles to prevent self-correlating symptoms to specific treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Urology patient at UCSF
- •Must own Android or iPhone smartphone, tablet, or computer
- •Taking tamsulosin for urinary-related symptoms
- •Able to speak and read English
- •Male 55-80 years old of age at telephone screening.
- •Written informed consent (and assent when applicable) obtained from subject or subject' s legal representative and ability for subject to comply with the requirements of the study.
- •Willing to receive electronic PERSONAL daily intake surveys for 3 months
- •Willing to self-report urinary symptom or medication side effect data at specified frequency.
- •Have home WiFi access.
- •Patients with h/o prostate cancer may be enrolled but is not required
- •Patients with h/o kidney stones may be enrolled but is not required
排除标准
- •Taking tamsulosin for <12 months.
- •International Prostate Symptom Score <5 or >25
- •Current participation in any other mobile app-based clinical study.
- •Planning to relocate from area within the study duration.
- •Impaired vision that could limit the use of the mobile apps (participant-reported)
研究组 & 干预措施
Tamsulosin 0.4 mg or 0.8 mg, Then Placebo
Participants first received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
干预措施: Tamsulosin (Drug)
Tamsulosin 0.4 mg or 0.8 mg, Then Placebo
Participants first received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
干预措施: Placebo (Drug)
Placebo, Then Tamsulosin 0.4 mg or 0.8 mg
Participants first received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
干预措施: Tamsulosin (Drug)
Placebo, Then Tamsulosin 0.4 mg or 0.8 mg
Participants first received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Adapted International Prostate Symptom Score (IPSS)
时间窗: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
Lower urinary tract symptoms will be measured using the adapted IPSS (recall period changed from 1 month to 24 hours). The score ranges from 0-35, with higher scores indicating more severe symptoms.
次要结局
- Medication Side Effect Scale(Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.)