The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 596
- 试验地点
- 12
- 主要终点
- Overactive Bladder Questionnaire short-form (OAB-q SF)
研究概览
简要总结
The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).
详细描述
In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts. RiSolve is a digital therapeutic device intended to provide behavioral therapy and cognitive behavioral therapy (CBT) for adult women who have been diagnosed with OAB, which includes urinary urgency with or without urge urinary incontinence (UUI), urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. RiSolve is indicated as an 8-week treatment to reduce the symptoms of OAB.
For the purposes of this trial, the primary outcome to determine improvement in OAB-related health will be defined as achieving the MID (defined as an improvement of 10 points or more) on the OAB-q SF Symptom Severity subscale after 8 weeks of treatment. Secondary outcomes will include achieving the MID on the OAB-q SF Health-Related Quality of Life subscale, meeting the patient's acceptable symptoms state (PASS) on the Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I), and improvements in frequency, nocturia and urge urinary incontinence (UUI) on a 3-day bladder diary and on the ICIQ-FLUTS. Participants will be randomized to either PDTx therapy (active) or standard treatment of behavioral education (control). Participants randomized to control will have the option to crossover to PDTx after the initial 8 weeks of the trial if desired. Participants will continue to be followed and asked about their symptoms at 6 and 12 months.
The impact of this trial has enormous potential to improve treatment of OAB. The ability to offer behavioral therapy via PDTx will reduce patient burden while simultaneously increasing quality of life for women suffering from OAB and decreasing provider burden. The high-quality data from this study will be used to support a marketing application with the FDA through the De Novo pathway for an accessible, low-burden, efficient intervention to help millions of women currently suffering from this burdensome condition.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 22 years old
- •Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)
- •English-speaking
- •Willing to forego other treatment outside of medications for the 8-week trial period
- •Use of at least one mobile App
排除标准
- •Stress-predominant mixed urinary incontinence (defined as QUID stress score > QUID urge score)
- •Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a
- •Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a
- •Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks
- •Currently using intermittent or indwelling catheter
- •History of bladder/urethral, colon/anal, or cervical cancer
- •Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection
- •Currently taking antibiotics/drugs for urinary tract infection^
- •Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period
- •Planning surgery for pelvic organ prolapse within 12 months of randomization
- •Pelvic surgery within the past 6 months
- •Planning to undergo pessary fitting °
- •Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting
- •https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ
研究组 & 干预措施
Intervention - RiSolve PDTx App
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
干预措施: RiSolve App (Device)
Control - Standard Therapy
Participants randomized to the control will receive a brief explanation of behavioral therapy with details provided in the form educational handouts including the American Urogynecologic Society (AUGS) "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets.
干预措施: AUGS Patient Handouts (Behavioral)
结局指标
主要结局
Overactive Bladder Questionnaire short-form (OAB-q SF)
时间窗: 8 Weeks
The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life,35 and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy.3 The scale ranges from 0 to 100 with a higher score indicating worse symptom severity. The MID is defined as a change of 10 points
次要结局
- OAB-q SF Health-Related Quality of Life (HRQL)(8 Weeks)
- Patient Global Impression of Severity (PGI-S)(8 Weeks)
- Patient Global Impression of Improvement (PGI-I)(8 Weeks)
- 3-Day Bladder Diary(8 Weeks)
- Questionnaire for Urinary Incontinence Diagnosis (QUID)(8 Weeks)
- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)(8 Weeks)
- Short Personal Experience Questionnaire (SPEQ)(8 Weeks)
- Adverse Events(12 Months)
- Mobile Application Rating Scale: user version (uMARS)(8 Weeks)
- Treatment Satisfaction(8 Weeks)
- Treatment accessibility(8 Weeks)
- Treatment adherence(8 Weeks)
- Other Treatments(12 Months)