Open-label, controlled, randomized, multicenter study to demonstrate the effect of the INKA digital therapy companion on symptoms of overactive bladder (with or without urinary incontinence).
- Conditions
- N32.8Other specified disorders of bladder
- Registration Number
- DRKS00032952
- Lead Sponsor
- Dr. Pfleger Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
1.Diagnosis of OAB with or without UI or mixed incontinence due to overactive bladder in combination with stress incontinence, when overactive bladder is the predominant symptom
2.Averaged daily micturition frequency at randomization of = 8 micturitions/day, collected with a 3-day bladder protocol according to ICIQ
3.Gender: male/female
4.Age: 18 years or older
5.Patients
owho have been receiving stable pharmacologic treatment1 for the above indications for at least =4 weeks prior to screening or
owho have not received (or have stopped receiving) pharmacological treatment1 for the named indications for = 4 weeks
6.Ability to read and write German.
7.Ownership and familiarity with a smartphone and ability to use it in daily life to respond to push messages, including regular use of mobile data away from home
8.Informed consent for study participation and data processing.
1.Regular, physiotherapy led pelvic floor muscle training in the last month (with or without app support)
2.Pure stress incontinence without OAB
3.Botulinum toxin treatment of the urinary bladder in the last 3 months
4.Pregnancy or breastfeeding
5.Lower urinary tract surgery with incomplete wound healing
6.Hematuria
7.Three or more urinary tract infections in the past 12 months
8.Severe heart failure (= NYHA III) or renal insufficiency (eGFR <45 ml/min)
9.Symptoms of overactive bladder resulting from previously diagnosed benign prostatic hyperplasia such as residual urine formation or condition after urinary retention
10.Known malignant diseases of the genitourinary tract, e.g. bladder cancer, prostate cancer
11.Neurological disease affecting the lower urinary tract (as judged by the investigator)
12.Other circumstances or diagnoses that, in the judgment of the investigator, may critically affect the symptomatology of OAB and/or otherwise compromise the safety of the patient during the study or the validity of the data obtained from the study (e.g. recurrent urolithiasis, severe diarrhoea)
13.Use of other apps with regard to bladder problems
14.Participation in another clinical trial within one month prior to enrolment in this study
15.Previous use of the INKA app
16.Current or planned pessary treatment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the medical benefit of the INKA digital therapy companion in terms of change in symptoms associated with OAB or mixed incontinence in relation to the number of daily micturitions (3-day bladder protocol according to ICIQ) in an integrated pooled analysis in patients receiving stable pharmacological treatment (OAB med cohort) and in patients not receiving pharmacological treatment (OAB naive cohort).
- Secondary Outcome Measures
Name Time Method Investigation of the effect of the digital therapy companion INKA on <br>•Disease-specific symptoms, measured with the 3-day bladder protocol according to ICIQ <br>•Symptoms and the impact on quality of life, measured with the ICIQ-OAB and ICIQ-OABqol questionnaires.<br>