Trial document

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DRKS-ID: DRKS00007109

Trial Description

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Title

Noninterventional 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

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Trial Acronym

NIS-056

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the course of this study the routine use of the registered drug Spasmex 45 mg coated tablets for the indication of overactive bladder will be documented for scientific purposes. Elderly (≥ 65 years of age) male and female patients will be enrolled in the study, who visit a urological practice due to symptoms of overactive bladder, and who receive prescription for Spasmex 45 mg coated tablets following routine diagnosis by the treating physician.
The aims of the study is to determine:
- the extent of anticholinergic drug burden with potential cognitive impairment
- the extent of morbidity
- efficacy and tolerability of the drug used
- divisibility of the coated tablet into three parts.

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Brief Summary in Scientific Language

Symptoms of an overactive bladder (OAB) (urgency, frequency and/or urge incontinence) are highly prevalent, with an increasing frequency in old age (Milsom et al. 2001). OAB affects the quality of life through to social isolation and depression (Griebling 2013). Multi-medication and additionally metabolites with anticholinergic effects may cause adverse reactions such as delirium, falls, cognitive impairment (Ancelin et al. 2006, Fox et al. 2011), and as a result lead to loss of independence (Pasina et al. 2013, Lertxundi et al. 2013), and to further deterioration of the patient's health status. Treatment with quarternary anticholinergic drugs, which are largely free of central nervous system effects, might be an approach for effective treatment of OAB without increasing the anticholinergic burden of the patients.
The described study with patients suffering from urge-symptoms will be divided into three parts:
a) an epidemiological survey
i. to determine the anticholinergic burden caused by drugs using the ACBS score and
ii. to determine and quantify the morbidity using the CIRS-G score.
b) a prospective investigation of efficacy and tolerabilty of Spasmex® 45mg coated tablets
c) a survey on the divisibility of Spasmex® 45mg coated tablets.

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Organizational Data

DRKS-ID: DRKS00007109
Date of Registration in DRKS: 2014/10/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2014-343-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster

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Secondary IDs

[---]*

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Health Condition or Problem studied

MedDRA: LLT,10059617:overactive bladder
ICD10: N32.8 - Other specified disorders of bladder

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Interventions/Observational Groups

Arm 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 visits is recommended.
It will be recorded:
1. Demographic data on visit 1
2. Symptoms of overactiv bladder on visit 1, 2, and 3
3. Morbidity using the CIRS-G questionnaire on visit 1
4. Medicinal pre-treatment on visit 1
5. Comedication with anticholinergic burden using the ACBS scale on visit 1, 2 and 3
6. Additional relevant comedication on visit 1, 2 and 3
7. Documentation of the therapy regimen
8. Questioning of physician and patient regarding efficacy and tolerability on visit 2 and 3
9. Questioning of patient regarding the divisibility of the coated tablet on visit 3
10. Questioning of patient regarding adverse events on visit 2 and 3.
11. Documentation of further treatment

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

Doctor's Practice Leipzig
Doctor's Practice Augsburg
Doctor's Practice Berlin
Doctor's Practice Bottrop
Doctor's Practice Brackenheim
Doctor's Practice Burghausen
Doctor's Practice Darmstadt
Doctor's Practice Dillenburg
Doctor's Practice Dossenheim
Doctor's Practice Dresden
Doctor's Practice Hamburg
Doctor's Practice Heilbronn
Doctor's Practice Köln
Doctor's Practice Lengerich
Doctor's Practice Ludwigshafen am Rhein
Doctor's Practice Magdeburg
Doctor's Practice Marburg
Doctor's Practice Markkleeberg
Doctor's Practice Neunkirchen
Doctor's Practice Pößneck
Doctor's Practice Reutlingen
Doctor's Practice Schwelm
Doctor's Practice Senftenberg
Doctor's Practice Sinsheim
Doctor's Practice Ahrensburg
Doctor's Practice Alzenau
Doctor's Practice Annaberg-Buchholz
Doctor's Practice Bad Doberan
Doctor's Practice Bad Nauheim
Doctor's Practice Bad Zwischenahn
Doctor's Practice Bamberg
Doctor's Practice Bergkamen
Doctor's Practice Bielefeld
Doctor's Practice Bocholt
Doctor's Practice Bochum
Doctor's Practice Chemnitz
Doctor's Practice Dinslaken
Doctor's Practice Dortmund
Doctor's Practice Düsseldorf
Doctor's Practice Ebersberg
Doctor's Practice Eilenburg
Doctor's Practice Erfurt
Doctor's Practice Essen
Doctor's Practice Flensburg
Doctor's Practice Gelsenkirchen
Doctor's Practice Gladbeck
Doctor's Practice Göppingen
Doctor's Practice Gotha
Doctor's Practice Gröbenzell
Doctor's Practice Groitzsch
Doctor's Practice Gummersbach
Doctor's Practice Halle Saale
Doctor's Practice Hamm
Doctor's Practice Hannover
Doctor's Practice Heinsberg
Doctor's Practice Herne
Doctor's Practice Herten
Doctor's Practice Heusweiler
Doctor's Practice Hildesheim
Doctor's Practice Holzminden
Doctor's Practice Homburg
Doctor's Practice Iserlohn
Doctor's Practice Kall
Doctor's Practice Kaltenkirchen
Doctor's Practice Krefeld
Doctor's Practice Langenfeld
Doctor's Practice Lemgo
Doctor's Practice Leutkirch
Doctor's Practice Leverkusen
Doctor's Practice Lichtenstein
Doctor's Practice Lippstadt
Doctor's Practice Ludwigsburg
Doctor's Practice Lutherstadt Eisleben
Doctor's Practice Mannheim
Doctor's Practice Mechernich
Doctor's Practice Miltenberg
Doctor's Practice Mönchengladbach
Doctor's Practice Mühlacker
Doctor's Practice Niederkassel
Doctor's Practice Nienburg
Doctor's Practice Nordhausen
Doctor's Practice Nordhorn
Doctor's Practice Nürnberg
Doctor's Practice Osnabrück
Doctor's Practice Papenburg
Doctor's Practice Potsdam
Doctor's Practice Prien
Doctor's Practice Rastatt
Doctor's Practice Regensburg
Doctor's Practice Rendsburg
Doctor's Practice Saarbrücken
Doctor's Practice Schwabach
Doctor's Practice Seesen
Doctor's Practice Stockach
Doctor's Practice Stralsund
Doctor's Practice Stuttgart
Doctor's Practice Tettnang
Doctor's Practice Tirschenreuth
Doctor's Practice Trier
Doctor's Practice Troisdorf
Doctor's Practice Velbert
Doctor's Practice Völklingen
Doctor's Practice Warstein
Doctor's Practice Wedel
Doctor's Practice Wesel
Doctor's Practice Witten
Doctor's Practice Zwickau
Doctor's Practice Baesweiler
Doctor's Practice Bautzen
Doctor's Practice Bogen
Doctor's Practice Brake
Doctor's Practice Bremen
Doctor's Practice Delmenhorst
Doctor's Practice Ergolding
Doctor's Practice Hemer
Doctor's Practice Kerpen-Sindorf
Doctor's Practice Rüsselsheim
Doctor's Practice Sömmerda
Doctor's Practice Wilhelmshaven

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2014/11/03
Target Sample Size: 1250
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 65 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

at least 65 years of age; symptoms of overactive bladder; prescription of Spasmex 45mg coated tablets

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Exclusion Criteria

younger than 65 years of age

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Addresses

Primary Sponsor
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- Dr. R. Pfleger GmbH
- 96045 Bamberg
- Germany
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- Telephone: 0951/6043-0
- Fax: 0951/6043-29
- E-mail: [---]*
- URL: http://www.dr-pfleger.de
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Collaborator, Other Address
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- Ev. Krankenhaus Witter gGmbHUrologische Klinik
- Mr. Priv.-Doz. Dr. med. Andreas Wiedemann
- Pferdebachstr. 27
- 58455 Witten
- Germany
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- Telephone: 02302/175-2521
- Fax: [---]*
- E-mail: awiedemann at diakonie-ruhr.de
- URL: http://www.evk-witten.de/ev_krankenhaus_witten/medizin/klinik_fuer_urologie
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Contact for Scientific Queries
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- Dr. R. Pfleger GmbH
- Ms. Dr. rer. nat. Claudia Neumeister
- Emil Kemmer Str. 33
- 96103 Hallstadt
- Germany
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- Telephone: 0951/6043-0
- Fax: 0951/6043-29
- E-mail: claudia.neumeister at dr-pfleger.de
- URL: http://www.dr-pfleger.de
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Contact for Public Queries
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- Dr. R. Pfleger GmbH
- Ms. Dr. rer. nat. Claudia Neumeister
- Emil Kemmer Str. 33
- 96103 Hallstadt
- Germany
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- Telephone: 0951/6043-0
- Fax: 0951/6043-29
- E-mail: nis-056 at dr-pfleger.de
- URL: http://www.dr-pfleger.de
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Dr. R. Pfleger GmbH
- 96045 Bamberg
- Germany
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- Telephone: 0951/6043-0
- Fax: 0951/6043-29
- E-mail: [---]*
- URL: http://www.dr-pfleger.de
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2015/10/30

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Trial Publications, Results and other Documents

Paper: Ivchenko et al. 2018 Anticholinergic burden and comorbidities

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