An observational study in Prostatic Hyperplasia, sponsored by Boehringer Ingelheim. Completed. Open to male participants. Per ClinicalTrials.gov, last updated 2014-09-19.
Sponsored by Boehringer Ingelheim · Observational
The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 3,629 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices
Exclusion Criteria:
No exclusion criteria is defined, prescribing information is to be considered
Drug: ALNA®
Also known as: tamsulosin
Change in obstructive BPH symptoms
Time frame: up to 12 weeks
Change in irritative BPH symptoms
Time frame: up to 12 weeks
Change in Residual Urine volume
Time frame: up to 12 weeks
Number of patients with adverse events
Time frame: up to 12 weeks
Assessment of the number of days on sick leave
Time frame: up to 12 weeks
Global assessment of efficacy by investigator on a 4-point scale
Time frame: after 12 weeks
Change in Quality-of-Life Index
Time frame: up to 12 weeks
Global assessment of tolerability by investigator on a 4-point scale
Time frame: after 12 weeks
Changes in urinary flow rate
Time frame: up to 12 weeks
No study locations are listed for this record.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim