DRKS00029595
Recruiting
未知
kontina(R) for the self-management of patients with overactive bladder - PEK-OAB
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- N32.8
- Sponsor
- APOGEPHA Arzneimittel GmbH
- Enrollment
- 208
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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