Status:
COMPLETED
Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
Veeda Clinical Research
Conditions:
Lower Urinary Tract Predominant Storage Symptoms
Eligibility:
MALE
18+ years
Brief Summary
This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will ...
Eligibility Criteria
Inclusion
- The following subjects can be included in this study if they answer the following criteria:
- they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC).
- Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator.
- IPSS storage sub-score \> 8
- Subject expected to require at least 3 months treatment with solifenacin.
Exclusion
- Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
- History of bladder obstruction not being adequately corrected.
- Anticipate or plan to participate in another study during study period of 12 weeks from study entry.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01799902
Start Date
December 1 2011
End Date
October 1 2013
Last Update
December 19 2013
Active Locations (15)
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1
ASZ
Aalst, Belgium, 9300
2
ZNA Stuyvenberg
Antwerp, Belgium, 2060
3
Erasme
Brussels, Belgium, 1070
4
UZ Brussel
Brussels, Belgium, 1090