Prospective randomized study of multimodal self-treatment of men with voiding dysfunction (LUTS) with a digital health applicatio
Not Applicable
- Conditions
- N40N32.8Hyperplasia of prostateOther specified disorders of bladder
- Registration Number
- DRKS00030935
- Lead Sponsor
- Kranus Health GmH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 237
Inclusion Criteria
Males with LUTS, OAB-q-SF Part 1 =11, or IPSS =4
Mastery of the German language
Internet access
Tablet or smartphone access
Informed Consent
Exclusion Criteria
Recurrent urinary retention
Recurrent urinary tract infections
bladder stones
Recurrent gross hematuria that cannot be controlled conservatively
Dilatation of the upper urinary tract, impaired renal function or renal insufficiency due to obstructive bladder emptying disorders
Newly started BPH drug therapy for the micturition symptoms (a-blockers, 5-a-reductase inhibitors, phytopharmaceuticals) in the last 4 weeks
Inability to physically participate in the program
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in IPSS from baseline to week 12<br>
- Secondary Outcome Measures
Name Time Method change in OAB-q-SF part 1 from baseline to week 12<br>change in OAB-q-SF part 2 from baseline to week 12change in micturition frequency during the day,<br>change in micturition frequency at night,<br>change in urge incontinence episode,<br>change in the imperative urge to urinate,<br>Change in functional bladder capacity<br>IPSS question 8, Likert scale 1-5<br>Reduction in the proportion of patients with treatment failure within the study period. Treatment failure is defined as an increase in IPSS = 3 points and/or OAB-q = 11 points, urinary retention, or the start of a new LUTS-specific medication or surgery.<br>Overall improvement after treatment (Likert scale of 1-7)<br>