Overactive Bladder (OAB) Clinical Trial
Official title:
An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)
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.
This is a post marketing, non-interventional study (NIS) of patients who are to be treated
with Vesitirim™. The decision whether or not to treat with Vesitirim™ will be made by the
treating physician prior to the entry of the patient into the study. The patient will be
informed of the study and written consent will be obtained prior to screening and
determination of eligibility.
No study drug will be supplied as part of this study.
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Observational Model: Cohort, Time Perspective: Prospective
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