Evaluating a Digital Intervention for Overactive Bladder: Protocol for a Single-arm, Multisite Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
研究概览
简要总结
Overactive Bladder is characterised by (I) Urgency: the sudden and compelling desire to pass urine with or without accidental leakage; (II) Frequency: the need to pass urine far more regularly than is considered normal; and (III) Nocturia: the need to pass urine several times during the night. This study aims to investigate the feasibility, acceptability and preliminary efficacy of a digital intervention (the NUIG OAB App) for overactive bladder. Furthermore, this study will help determine the most appropriate outcomes for use in the future definitive RCT and the effect size for future sample size calculations. Participants will complete an 8-week intervention designed to reduce the symptoms of OAB, delivered through the NUIG OAB App. Participants will be asked to complete online surveys at baseline, 4 weeks and 8 weeks and an in-app Bladder Diary at weeks 1 and 8. There will be no in-person contact with participants by the study team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •On waiting list for Urogynaecologist at participating hospital
- •Referred for Overactive bladder from GP
- •Symptoms of Overactive bladder to include at least one of the following: urgency of urination, frequency of urination or urge incontinence.
- •18 years or older
- •Own a smartphone
排除标准
- •Active/Recurrent urinary tract infection
- •Urinary retention
- •Bladder Pain Syndrome/ interstitial cystitis
- •Pelvic/gynae cancer
- •Kidney problems
- •Have/had a neuro-stimulation implant for treatment of OAB
研究组 & 干预措施
NUIG OAB App
Digital behaviour change intervention. Software-delivered intervention including best-practice behavioural therapy, and evidence-based dietetics, physiotherapy and psychology treatments to reduce the symptoms of overactive bladder.
干预措施: NUIG OAB App (Behavioral)
结局指标
主要结局
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
时间窗: baseline and week 8
Change from baseline patient-reported overactive bladder related quality of life at week 8. Minimum score 25, maximum score 160. Greater values indicating increased impact on quality of life
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
时间窗: baseline and week 8
Change from baseline patient-reported overactive bladder symptoms at week 8. Minimum score 0, maximum score 16. Greater values indicate increased symptom severity.
Change in Digital Bladder Diary frequency of urination
时间窗: baseline & week 8
Change from baseline frequency of urination at week 8. Frequency of urination measured in-app, in real-time as number of urinations per day logged by user for 3 days at baseline and 3 days in week 8.
次要结局
- Mobile Applications Rating Scale, user version (MARSu)(week 4)
- Programme adherence(data collected throughout the 8 week intervention.)
- Patient Global impression of improvement(week 8)
- Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)(baseline and week 4)
- Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)(baseline and week 4)
研究者
Emma Carr
Researcher
National University of Ireland, Galway, Ireland