Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-16 @ 6:47 AM
Study NCT ID:
NCT01639794
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2012-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vesitirim™ in Men Postmarketing Observational Study
Sponsor:
Astellas Pharma Europe Ltd.
Organization:
Study Overview
Official Title:
An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIM
Brief 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.
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.
Detailed Description:
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.
No study drug will be supplied as part of this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: