Vesitirim™ in Men Postmarketing Observational Study (VIM)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB); Lower Urinary Tract Symptoms (LUTS)
• Intervention / Treatment: Drug: Vesitirim™ (Solifenacin)

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Site 2 - Mercy University Hospital
  • Dublin, Ireland, 24
    • Site: 4 - Tallaght Hospital
  • Dublin, Ireland, 8
    • Site: 1 - St James Hopsital
  • Dublin, Ireland, 9
    • Site: 5 - Beaumont Hospital
  • Sligo, Ireland
    • Site: 3 - Sligo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified from the Consultants routine clinics and the decision to treat a patient with Vesitirim™ will be made by the treating physician prior to enrolment into this non interventional study

Description

Inclusion Criteria:

• Diagnosis of non-neurogenic Lower Urinary Tract Symptoms (LUTS) with bothersome storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the Investigator
• Eligible to start Vesitirim™ 5 or 10mg according to SmPC (Summary of Product Characteristics )

Exclusion Criteria:

• History of stress incontinence
• Active urinary tract infection (confirmed by positive urine analysis)
• Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Qmax<10ml/sc and/or PVR>150ml
• History of known hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form or any other allergy, which, in the opinion of the Investigator contraindicates their participation
• Uncontrolled Diabetes Mellitus
• History of drug and/or alcohol abuse at the time of enrolment
• History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk of these conditions
• Undergoing haemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
• History of urogenital tumours which in the opinion of the Investigator precludes their participation in the study
• Likely to participate in another study during study period of 12 weeks from study entry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Oral; Other Names: Solifenacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Chair: Medical Director, Astellas Pharma Co. Ltd (APCL)

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (ESTIMATE): July 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Solifenacin; LUTS (Lower Urinary Tract Symptoms); Overactive Bladder (OAB)Vesitirim; Anti-muscarinic treatment; Cholinergic receptor antagonist; Storage Symptom improvement
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: VES-IE-001