kontina(R) for the self-management of patients with overactive bladder
- Conditions
- N32.8N39.42Other specified disorders of bladder
- Registration Number
- DRKS00029595
- Lead Sponsor
- APOGEPHA Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 208
1) Male and female subjects aged at least 18 years
2) Subjects with OAB
- with or without urgency urinary incontinence (UUI) OR
- with or without mixed urinary incontinence (MUI) for which the investigator determines that UUI is predominant to the subject
3) Subjects with a history of symptoms of OAB (at least three months) who are treatment-naïve or stopped prior OAB treatment at least four weeks ago and for whom behavioral therapy, lifestyle interventions or physiotherapy measures are indicated
4) At least eight micturitions in 24 hrs
5) BMI from 18 to less than 40 kg/m2
6) Subjects who have access to a mobile device and are skilled in the use of it
7) Subjects who are able to understand, read and write German
8) Willing and capable of providing informed consent to use kontina® and participate in all assessments associated with the clinical study
9) In possession of a smartphone and willing and able to use it for study purposes
1) Use of other PFMT app or bladder training app
2) Red-flag symptoms and genitourinary conditions:
- Stress urinary incontinence
- Painful urgency
- Acute or Recurrent urinary tract infections (2 UTIs in the last 6 months or = 3 UTIs in the last 12 months)
- Macroscopic or microscopic haematuria
- Non-investigated bladder emptying difficulties
- Suspicion of or known anomalies of the lower urinary tract (according to assessment by or in the opinion of the investigator)
- Suspicion of or known cancer in bladder or pelvic area (according to assessment by or in the opinion of the investigator)
- Intermittent catheterization
- Surgery of the lower genitourinary tract within the last 12 months before study inclusion (e.g., prostatectomy, hysterectomy, tapes)
3) Intravesical botulinum toxin injections within the last 18 months
4) Sacral nerve stimulation
5) Male patients with OAB and benign prostate hyperplasia with predominant obstructive symptoms
6) Suspicion of or known pregnancy
7) Suspicion of or known neurological disorders (e.g., neurogenic bladder dysfunction, multiple sclerosis)
8) Uncontrolled Diabetes mellitus
9) Subjects with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
10) Subjects who participated in another clinical study with an investigational drug within the last month prior to inclusion in this clinical study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from baseline in OAB-related HRQoL (OAB-q) at week 12<br>2. Change from baseline in mean number of micturitions/ 24 hrs at week 12
- Secondary Outcome Measures
Name Time Method 1. Change from baseline in OAB-related HRQoL at week 6<br>2. Change from baseline in mean number of micturitions/24 hrs at week 6<br>3. Change from baseline in OAB-related symptom bother at weeks 6 and 12<br>4. Change from baseline in ICIQ-UI SF in patients with urinary incontinence at weeks 6 and12<br>5. Change from baseline in mean number of urgency episodes/24 hrs at weeks 6 and 12<br>6. Change from baseline in mean number of urinary incontinence/24 hrs in patients with urinary incontinence at weeks 6 and 12