Vesitirim™ in Men Postmarketing Observational Study
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
This is an observational study which will look at the improvement in Lower Urinary Tract
Symptoms (LUTS) in Irish men being treated with Vesitirim™ (solifenacin).
Vesitirim™ is a competitive specific muscarinic receptor antagonist and has been used
extensively for the treatment of OAB (Over Active Bladder) in women and has shown significant
impact on urgency, frequency and incontinence in females. It is also indicated for the
symptomatic treatment of urgency incontinence and/or increased urinary frequency and urgency
in men. The purpose of this study is to evaluate LUTS storage symptom improvement in men with
non neurogenic LUTS who have been prescribed Vesitirim™.
The effect of Vesitirim (solifenacin) treatment on bothersome symptoms improvement will be
measured using Over Active Bladder-q Short Form (OAB-qSF) and the Perception of Treatment
Satisfaction (TS-VAS). The study will also help define some of the characteristics of the
male population in Ireland who are treated with Vesitirim™ (solifenacin) as well as
evaluating the effect of Vesitirim™ monotherapy or combination therapy on storage symptoms
improvement (urgency, frequency and urge incontinence) using a bladder diary and IPSS
(International Prostate Symptom Score). The study will also evaluate the effect of Vesitirim™
monotherapy or combination therapy on nocturia using IPSS. The impact of LUTS on quality of
life will also be assessed. Data will also be collected regarding adverse drug reactions.