oninterventional study on the administration of Spasmex® 45 mg coated tablets in elderly female and male patients suffering from symptoms of urge in daily urological practice - a noninterventional study with epidemiological aspects
- Conditions
- MedDRA - LLT,10059617:overactive bladderN32.8Other specified disorders of bladder
- Registration Number
- DRKS00007109
- Lead Sponsor
- Dr. R. Pfleger GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1007
Inclusion Criteria
at least 65 years of age; symptoms of overactive bladder; prescription of Spasmex 45mg coated tablets
Exclusion Criteria
younger than 65 years of age
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>b) to determine and quantify the morbidity using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) on visit 1<br>c) to detemine the efficacy using the following parameters:<br>- number of micturitions per day (on visit 1, 2 and 3)<br>- intensity of urgency (on visit 1, 2 and 3)<br>- incontinence episodes (on visit 1, 2 and 3)<br>- overall assessment of efficacy by patient and by physician (on visit 2 and 3)<br>d) to determine the divisibility of the coated tablets using an ordinal scale (on visit 3)<br>e) overall assessment of tolerability by patient and by physician (on visit 2 and 3)<br>f) documentation of side effects (on visit 2 and 3)<br>A period of time of at least 10 days between the visits is recommended.<br>
- Secondary Outcome Measures
Name Time Method 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.