Vesitirim™ in Men Postmarketing Observational Study (VIM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01639794
First received: July 11, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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 Intervention
Lower Urinary Tract Symptoms (LUTS)
Overactive Bladder (OAB)
Drug: Vesitirim™ (Solifenacin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to visit 2 in voiding function assessed by Qmax and PVR [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to visit 2 in quality of life assessed by IPSS score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Adverse drug reactions- incidence of acute urinary retention and urinary tract infection [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639794

Locations
Ireland
Site 2 - Mercy University Hospital
Cork, Ireland
Site: 1 - St James Hopsital
Dublin, Ireland, 8
Site: 4 - Tallaght Hospital
Dublin, Ireland, 24
Site: 5 - Beaumont Hospital
Dublin, Ireland, 9
Site: 3 - Sligo General Hospital
Sligo, Ireland
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Chair: Medical Director Astellas Pharma Co. Ltd (APCL)
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01639794     History of Changes
Other Study ID Numbers: VES-IE-001
Study First Received: July 11, 2012
Last Updated: January 16, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by Astellas Pharma Inc:
LUTS (Lower Urinary Tract Symptoms)
Overactive Bladder (OAB)Vesitirim
Solifenacin
Anti-muscarinic treatment
Cholinergic receptor antagonist
Storage Symptom improvement

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014