Vesitirim™ in Men Postmarketing Observational Study

Overactive Bladder (OAB) Clinical Trial

— VIM  

Official title:

An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639794
• Other study ID #: VES-IE-001
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: January 16, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms (LUTS)
• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• Vesitirim™ (Solifenacin)
Oral

Locations

Country	Name	City	State
Ireland	Site 2 - Mercy University Hospital	Cork
Ireland	Site: 1 - St James Hopsital	Dublin
Ireland	Site: 4 - Tallaght Hospital	Dublin
Ireland	Site: 5 - Beaumont Hospital	Dublin
Ireland	Site: 3 - Sligo General Hospital	Sligo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score		Baseline and 12 weeks	No
Primary	Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS)		Baseline and 12 weeks	No
Secondary	Change from baseline to visit 2 in voiding function assessed by Qmax and PVR		Baseline and 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline to visit 2 in quality of life assessed by IPSS score		Baseline and 12 weeks	No
Secondary	Adverse drug reactions- incidence of acute urinary retention and urinary tract infection		Baseline and 12 weeks	Yes