A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Patient Satisfaction
研究概览
简要总结
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).
详细描述
This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry
排除标准
- •Active Urinary Tract Infection (UTI)
- •Stage 3 or 4 prolapse
- •Underlying neurologic condition contributing to OAB
- •Use of catheter
研究组 & 干预措施
Traditional In-Person Clinic Visit Arm
Patients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person
干预措施: SUFU Clinical Care Pathway for Overactive Bladder (Other)
Telemedicine Arm
Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
干预措施: SUFU Clinical Care Pathway for Overactive Bladder (Other)
Telemedicine Arm
Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
干预措施: Telemedicine (Other)
结局指标
主要结局
Patient Satisfaction
时间窗: 1 year
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
次要结局
- Accumulated cost of visit to patient (Cost)(1 year)
- PGII(1 year)
- Incidence of Treatment-emergent adverse events (safety and tolerability)(1 year)
- Overactive Bladder Symptoms(1 year)
- Accumulated time of visit for patient (Time)(1 year)
研究者
Victor W. Nitti, MD
Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery
University of California, Los Angeles