Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
试验速览
- 阶段
- 不适用
- 发起方
- Renalis
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of overactive bladder quality of life measure
研究概览
简要总结
This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.
详细描述
The investigators seek to evaluate a commercial digital therapeutic, called CeCe, designed to provide first-line behavioral modification therapy for overactive bladder (OAB). This digital platform provides daily contact with the user to maximize compliance. It allows a provider to administer behavioral modification treatment while minimizing in-office visits.
The investigators expect that a proportion of participants using Cece will experience significant and satisfactory improvement in their voiding symptoms, to the point where no further treatment is necessary. Others will require additional treatment with the usual therapies such physical therapy and medications, per clinical standards.
Participants will download CeCe to their smart phones and interact with the program for 8 weeks. Participant consent and specific instructions will be provided during study enrollment and through the app. Study outcomes are collected through the program via in-app questionnaires and voiding diaries.
A total of 50 participants will be recruited. They will be compensated a total sum of $175; $50 at completion of an initial set of questionnaires, $50 at completion of 4 week follow-up questionnaires, and $75 at completion of 8 week follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptoms of overactive bladder with urgency urinary incontinence, with or without nocturia/nocturnal enuresis
- •Symptoms of mixed urinary incontinence if urgency incontinence is the predominant complaint
- •Post-void residual <100ml
- •English speaking
- •Access to a smartphone
- •Normal urinalysis without evidence of UTI, gross or microscopic hematuria
- •Greater than 6 months since receiving intradetrusor injection of botulinum toxin
- •Not currently undergoing sacral neuromodulation therapy
- •Not currently receiving pharmacotherapy for overactive bladder
排除标准
- •Less than 40 years of age
- •Mixed incontinence with predominant stress urinary incontinence symptoms
- •Diagnosis of chronic pelvic pain
- •symptomatic pelvic organ prolapse
- •symptoms of dysuria
- •Diagnosis of interstitial cystitis/painful bladder syndrome
- •Reported >2 UTI in 6 months or >3 in 12 months
- •Do not have access to a smartphone
- •Non-English speaking
- •Diagnosis of neurogenic bladder
- •Gross or microscopic hematuria
- •Has diagnosis of dementia, cognitive impairment or other neurologic condition which impairs decision making
- •Current Pharmacotherapy or neuromodulation therapy
- •Less than 6 months since intradetrusor botulinum toxin injection
- •Has decreased mobility or ambulation
- •Has post-void residual >100 mL
- •Has BMI > 40 kg/m^2
- •Inability to voluntarily contract the pelvic floor muscles (a 0/5 in strength).
- •Has >4/10 pain with palpation of levator ani, coccygeus, pyriformis, obturator internus or perineal body
结局指标
主要结局
Change of overactive bladder quality of life measure
时间窗: Baseline, 4 weeks, and 8 weeks
International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life questionnaire (ICIQ-OAB-QoL) is a 26 item questionnaire evaluating quality of life (QoL) in patients with overactive bladder. Scores range from 25-160, with greater values indicating increased impact on quality of life.
次要结局
- Mobile device proficiency(Baseline)
- Change in anxiety(Baseline, 4 weeks, and 8 weeks)
- Usability(8 weeks)
- Change in symptoms of Overactive bladder(Baseline, 4 weeks, and 8 weeks)
- Change in general health state(Baseline, 4 weeks, and 8 weeks)
- Global impression of improvement(At 8 weeks)