Vesitirim™ in Men Postmarketing Observational Study (VIM)
|ClinicalTrials.gov Identifier: NCT01639794|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : January 17, 2013
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.
|Condition or disease||Intervention/treatment|
|Lower Urinary Tract Symptoms (LUTS) Overactive Bladder (OAB)||Drug: Vesitirim™ (Solifenacin)|
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.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)|
|Study Start Date :||February 2012|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Male patients with non-neurogenic LUTS taking VESITRIM
Male patients diagnosed with non-neurogenic Lower Urinary Tract Symptoms (LUTS) with bothersome storage disorder defined as urgency, and/or frequency and/or Urgency Urinary Incontinence (UUI)
Drug: Vesitirim™ (Solifenacin)
Other Name: Solifenacin
- Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score [ Time Frame: Baseline and 12 weeks ]
- Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS) [ Time Frame: Baseline and 12 weeks ]
- Change from baseline to visit 2 in voiding function assessed by Qmax and PVR [ Time Frame: Baseline and 12 weeks ]
- Change from baseline to visit 2 in patient perception of voiding symptoms assessed by: IPSS scores and number of urge incontinence (UUI) episodes per week [ Time Frame: Baseline and 12 weeks ]
- Change from baseline to visit 2 in storage symptoms assessed by micturition diary; number of urgency episodes per 24 hours; number of micturition per 24 hours and number of nocturia episodes per 24 hours [ Time Frame: Baseline and 12 weeks ]
- Change from baseline to visit 2 in quality of life assessed by IPSS score [ Time Frame: Baseline and 12 weeks ]
- Adverse drug reactions- incidence of acute urinary retention and urinary tract infection [ Time Frame: Baseline and 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639794
|Site 2 - Mercy University Hospital|
|Site: 4 - Tallaght Hospital|
|Dublin, Ireland, 24|
|Site: 1 - St James Hopsital|
|Dublin, Ireland, 8|
|Site: 5 - Beaumont Hospital|
|Dublin, Ireland, 9|
|Site: 3 - Sligo General Hospital|
|Study Chair:||Medical Director||Astellas Pharma Co. Ltd (APCL)|