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

Not Applicable

Recruiting

• Conditions: N39.3; N39.42; Stress incontinence

• Registration Number: DRKS00033704
• Lead Sponsor: Kranus Health GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

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

Exclusion Criteria

1. absolute contraindications that can be coded according to ICD-10 (incl. ICD-10 codes):

None

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

Pregnancy

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative change (rel-CfB-IEF) in IEF from baseline to week 12 in relation to baseline; desired reduction in mean relative IEF by 50 %; IEF per 24 hours - averaged over 72 hours.