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This is an observational study which will look at the improvement in Lower Urinary Tract Symptoms (LUTS) in Irish men being treated with Vesitirimâ„¢ (solifenacin).
Vesitirimâ„¢ 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 Vesitirimâ„¢.
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 Vesitirimâ„¢ (solifenacin) as well as evaluating the effect of Vesitirimâ„¢ 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 Vesitirimâ„¢ 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 Vesitirimâ„¢. The decision whether or not to treat with Vesitirimâ„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesitirimâ„¢ (Solifenacin) | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score | Baseline and 12 weeks | |
| Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS) | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to visit 2 in voiding function assessed by Qmax and PVR | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be identified from the Consultants routine clinics and the decision to treat a patient with Vesitirimâ„¢ will be made by the treating physician prior to enrolment into this non interventional study
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Co. Ltd (APCL) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 - Mercy University Hospital | Cork | Ireland | ||||
| Site: 4 - Tallaght Hospital |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| 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 | Baseline and 12 weeks |
| Change from baseline to visit 2 in quality of life assessed by IPSS score | Baseline and 12 weeks |
| Adverse drug reactions- incidence of acute urinary retention and urinary tract infection | Baseline and 12 weeks |
| Dublin |
| 24 |
| Ireland |
| Site: 1 - St James Hopsital | Dublin | 8 | Ireland |
| Site: 5 - Beaumont Hospital | Dublin | 9 | Ireland |
| Site: 3 - Sligo General Hospital | Sligo | Ireland |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |