Prospective randomised study on multimodal self-treatment of women with incontinence complaints using a digital health application

Kranus Health GmbH0 个研究点目标入组 198 人开始时间: 2024年4月26日最近更新: 2024年8月19日

适应症

试验速览

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•Women with urge incontinence, stress incontinence, mixed incontinence (IE = 1 per day)
•Mastery of the German language
•Internet access
•Tablet or smartphone access (Android not older than version 7 and iPhone not older than iPhone 9)
•Informed consent

•1. absolute contraindications that can be coded according to ICD-10 (incl. ICD-10 codes):
•2. absolute contraindications that cannot be coded according to ICD-10:
•Age under 18 years
•Botulinum toxin treatment of the urinary bladder in the last 6 months
•Acute urinary tract infection
•3. relative exclusion criteria that can be coded according to ICD-10 (incl. ICD-10 codes):
•Recurrent urinary tract infections N 39.0
•Urinary bladder calculi N 21.0
•Recurrent macrohaematuria that cannot be managed conservatively R31
•Newly diagnosed bladder carcinoma < 3 months C67
•4. relative exclusion criteria that cannot be coded according to ICD-10
•Inability to physically participate in the treatment programme
•5. study-specific methodological exclusion criteria:
•Generally patients who are unable to understand and independently sign the informed consent form
•Newly initiated drug or physical therapy for micturition symptoms (anticholinergics, beta-3 receptor agonists, phytopharmaceuticals, biofeedback, EMS) in the last 4 weeks
•Severe psychiatric disorders that make it impossible to use the app
•Neurological disorders that affect the urinary tract
•Surgery in the small pelvis including incontinence surgery
•Obesity per magna (BMI >35)

发起方