SiRE

• Research type

  Research Study

• Full title

  Effectiveness and safety of silodosin in the treatment of LUTS in patients with benign Prostatic Hyperplasia: a European phase IV clinical study (the Silodosin in Real-life Evaluation study)

• IRAS ID

  75162

• Contact name

  Christopher Chapple

• Sponsor organisation

  RECORDATI S.p.A

• Eudract number

  2011-000045-20

• Research summary

  A Clinical Study to assess the Effectiveness and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Patients with Benign Prostatic Hyperplasia.Benign prostatic hyperplasia (BPH) is a disease characterised by a non-cancerous enlargement of the prostate gland. It is estimated to affect the quality-of-life of about a third of the men in their seventies in the United Kingdom. If left untreated, serious complications as urinary tract infections or an impaired kidney function can occur.Silodosin is a new drug which belongs to the so-called alpha-1A-adrenoreceptor blockers, acting by selective relaxation of smooth muscles in the prostate, bladder and urethra. Urinary symptoms in patients with BPH are caused by the blockage of urine outflow because of a stricture and compression on the urethral canal where the urine flows. Silodosin makes it easier to pass water and relieves the symptoms. It has received a marketing approval in all European countries and is presently marketed under the trade names Urorec© and Silodyx©.The efficacy and safety of silodosin has been proved within several clinical studies. The objective of the current study, funded by Recordati S.p.A., is to confirm this positive benefit-risk evaluation of silodosin under ??real-life conditions?? in a larger and less selected population of patients.The study will last up to 28 weeks and will include 5 visits at the study centre. The treatment will consist of 1 capsule of silodosin 8 mg once daily for 24 weeks. For the patients, the study will include the following procedures: physical examination, digital rectal examination which may cause some discomfort, blood pressure and pulse measurements, electrocardiogram, routine blood and urine samples (at the beginning and end of the study), completion of three questionnaires and completion of a frequency/volume diary.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0079

• Date of REC Opinion

  17 Jun 2011

• REC opinion

  Further Information Favourable Opinion