overactive bladder
Conditions
Interventions
Group 1: Control
Group 2: INKA-App
Sponsors
NEXTEC medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of OAB for = 4 weeks with or without UI or mixed incontinence due to overactive bladder combined with stress incontinence if overactive bladder is the predominant symptom 2. Sex: male/female 3. Age: 18 years or older 4. Patients receiving stable pharmacological treatment for included indications for at least =4 weeks before screening visit 5. Ability to read and write German 6. Ownership and familiarity to a smartphone and capability to use it in daily life, to react on push messages 7. Informed consent to study participation and data processing
Exclusion criteria
Exclusion criteria: 1. Ongoing pregnancy or breastfeeding 2. Severe heart insufficiency (= NYHA III) 3. Severe kidney insufficiency (eGFR <45 ml/min) 4. Lower urinary tract surgery with incomplete wound healing 5. Known malignancy in lower genito-urinary tract e.g. bladder cancer, prostate cancer 6. Visual blood in urine 7. Three or more urinary tract infections during the last 12 months 8. Severe psychiatric disorder possibly resulting in noncompliance (as judged by the investigator) 9. Regular pelvic floor muscle training during the last month (with or without support by an app) 10. Neurological disease affecting the urinary tract (as judged by the investigator) 11. Pure stress incontinence without OAB 12. Current Botulinum toxin treatment of the urinary bladder 13. Symptoms of an overactive bladder originating from a previously diagnosed benign prostatic hyperplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean number of micturitions per day (average from 3-day bladder protocol) after 12 weeks using the INKA app as compared to control group without INKA app. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to 4 weeks based on 3-day bladder protocol - in the mean number of micturitions per day (average from 3-day bladder protocol) Change from baseline to 4 and to 12 weeks based on 3-day bladder protocol - in the mean urine volume (ml) per micturition - in the mean number of PADs (n) used per day - in the mean intensity of urge (score 0-4) - in the mean number of micturitions (n) during the day (6 am - 10 pm) - in the mean number of micturitions (n) during night (10 pm - 6 am) - in the mean number of urine leakage (n) per day Change from baseline to 4 and to 12 weeks based on the pad test - in the mean amount of urine loss in g per day Change from baseline to 4 and to 12 weeks based on questionnaires - in the overall score of the quality-of-life questionnaire ICIQOABqol - in the total score of the questionnaire ICIQ-OAB - in the total score of the questionnaire ICIQ-UI-SF | — |
Countries
Germany
Contacts
Public ContactAndreas Wiedemann
Ev. Krankenhaus Witten gGmbH
Outcome results
None listed