Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Incontinence Episodes
研究概览
简要总结
This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes.
详细描述
The intervention in this study involves a digital therapy program delivered via a smartphone or tablet application. This program includes several components aimed at addressing different aspects of incontinence management:
Voiding Diary: Participants will be instructed to maintain a diary to track their urinary habits, including frequency of voiding, episodes of incontinence, and fluid intake.
Pelvic Floor Exercises and Physiotherapy: The digital therapy program will provide guidance on performing pelvic floor exercises and other physiotherapeutic interventions aimed at strengthening pelvic floor muscles and improving bladder control.
Bladder Training and Cognitive Behavioral Therapy: Participants will receive instructions on bladder training techniques and cognitive behavioral strategies to manage urgency and frequency of urination.
Mental Exercises: The program will include mental exercises such as mindfulness techniques, progressive muscle relaxation, and stimulus control methods to help participants manage stress, anxiety, and other psychological factors contributing to incontinence.
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
- Single (Investigator)
盲法说明
Participants know which group they are assigned to, but the investigators are blinded.
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
- •Women aged 18 years or older.
- •Diagnosis of urinary incontinence, including stress incontinence, urge incontinence, or mixed incontinence.
- •Mastery of the German language.
- •Access to the internet.
- •Access to a tablet or smartphone (Android not older than version 7 and iPhone not older than iPhone 9).
- •Ability to provide informed consent
排除标准
- •Acute cystitis (N30.0)
- •Bladder stones (N21.0)
- •Recurrent, uncontrollable macrohematuria (R31)
- •Newly diagnosed bladder carcinoma < 3 months (C67)
- •Relative Exclusion Criteria not coded according to ICD-10:
- •Inability to physically participate in the therapy program
- •Active pregnancy
- •Bladder botulinum toxin treatment within the last 6 months
- •Study-specific methodological exclusion criteria:
- •Patients unable to understand and independently sign the consent form
- •Initiation of new medication or physical therapy for urinary symptoms within the last 4 weeks
- •Severe psychiatric disorders hindering app usage
- •Neurological disorders affecting the urinary tract
- •Incontinence or tumor surgeries in the pelvic area
- •Severe obesity (BMI >35)
- •Recurrent urinary tract infections (at least 2 within 6 months or 3 within a year)
研究组 & 干预措施
Intervention
Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care
干预措施: Kranus Mictera (Device)
Control
Participants will continue with their therapy treatment (standard of care) if they are on it for more that four weeks before inclusion. Beginning of new therapies during the study is not allowed.
结局指标
主要结局
Incontinence Episodes
时间窗: 12 weeks
Relative change (rel-CfB-IEF) of IEF from baseline to week 12 relative to baseline; desired reduction in mean relative IEF by 50%; IEF per 24 hours - averaged over 72 hours.
次要结局
- Urinary Frequency in OAB/ Mixed Group(12 weeks)
- International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)(12 weeks)
- Incontinence Quality-of-Life (I-QOL)(12 weeks)
- Patient Activation Measure-13 (PAM-13)(12 weeks)
- Patient Global Impression of Improvement (PGI-I)(12 weeks)
- Cured Patients(12 weeks)
- Urinary Frequency Day(12 weeks)
- Urinary Frequency Night(12 weeks)
- Pad Use(12 weeks)
- Urge Incontinence(12 weeks)
- Functional Bladder Capacity(12 weeks)
- Number of Participants With Treatment Failure(12 weeks)
- Stress Urinary Incontinence Episodes of the S/U-IQ(12 weeks)
- Urgency Urinary Incontinence Episodes of the S/U-IQ(12 weeks)