MedDRA - LLT,10059617:overactive bladder N32.8
Conditions
Interventions
Group 1: There is only one treatment arm. There are 3 visits per patient. The period of time between the visits corresponds to the general practice. A period of time of at least 10 days between the vi
Sponsors
Dr. R. Pfleger GmbH
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: at least 65 years of age; symptoms of overactive bladder; prescription of Spasmex 45mg coated tablets
Exclusion criteria
Exclusion criteria: younger than 65 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) to determine the anticholinergic burden caused by drugs using the total score of Anticholinergic Cognitive Burden Scale (ACBS) on visit 1, 2 and 3 b) to determine and quantify the morbidity using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) on visit 1 c) to detemine the efficacy using the following parameters: - number of micturitions per day (on visit 1, 2 and 3) - intensity of urgency (on visit 1, 2 and 3) - incontinence episodes (on visit 1, 2 and 3) - overall assessment of efficacy by patient and by physician (on visit 2 and 3) d) to determine the divisibility of the coated tablets using an ordinal scale (on visit 3) e) overall assessment of tolerability by patient and by physician (on visit 2 and 3) f) documentation of side effects (on visit 2 and 3) A period of time of at least 10 days between the visits is recommended. | — |
Secondary
| Measure | Time frame |
|---|---|
| See Primary outcome. In this noninterventional study there are no primary or secondary endpoints. All variables will be evaluated descriptively. No hypothesis will be tested, no comparison of different populations will be done. | — |
Countries
Germany
Contacts
Public ContactClaudia Neumeister
Dr. R. Pfleger GmbH
Outcome results
None listed