Effect of Text Message Reminders on Michigan Incontinence Symptom Index Score After Prostate Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Time to Recovery to Continence
研究概览
简要总结
The purpose of this study is to compare post-prostatectomy incontinence via Michigan Incontinence Score Index in patients receiving daily text message reminders for pelvic floor exercises when compared to those not receiving text reminders.
详细描述
This trial will be comprised of prostate cancer patients who have undergone a radical prostatectomy and benign prostate hyperplasia patients who have undergone a laser enucleation of the prostate. These two cohorts will each be split into an intervention and a control group. The purpose of this study is to evaluate post-prostatectomy incontinence via patient reported outcomes utilizing Michigan Incontinence Score Index in patients receiving daily text message reminders for pelvic floor exercises + standard of care (intervention group) compared to those receiving standard of care only (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Planning to undergo a radical prostatectomy (RALP) or laser enucleation of the prostate (LEP) procedure
- •Patient of URMC Urology
- •Adult male 18 years of age and older
- •Able to read, write, and speak in English (NOTE: due to limitations with questionnaire validation, only English-speaking subjects are permitted)
- •Has access to a mobile device capable of receiving automated text messages.
- •Willing to receive text messages and to complete questionnaires via SMS text.
- •Willingness to participate and able to provide informed consent.
排除标准
- •Less than 18 years of age
- •Unable to send and receive SMS texts
- •Unable to read, write, and speak English
- •Catheter dependency
- •Has or plans to have Artificial Urinary Sphincter or Urethral Sling during the study period
- •In the opinion of the investigator, the subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate.
研究组 & 干预措施
Control group - LEP surgery patients
Patients undergoing LEP surgery and standard of care discharge instructions to perform pelvic floor exercises
Intervention group - LEP surgery patients
Patient undergoing LEP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events
干预措施: Text message reminders (Behavioral)
Control group - RALP surgery patients
Patients undergoing RALP surgery and standard of care discharge instructions to perform pelvic floor exercises
Intervention group - RALP surgery patients
Patient undergoing RALP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events
干预措施: Text message reminders (Behavioral)
结局指标
主要结局
Time to Recovery to Continence
时间窗: From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 months
The time it takes for participants to recover continence, as defined by two successive M-ISI Pad Use Subdomain Scores of ≤ 2. The Pad Use Subdomain Score is determined by the sum of items Q7-8 from the M-ISI questionnaire, assessed as a time-to-event outcome.
次要结局
未报告次要终点
研究者
Scott Quarrier
Assistant professor
University of Rochester