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Completed

NCT Number: NCT01639794

Vesitirim™ in Men Postmarketing Observational Study

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.

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Key information

Conditions

Lower Urinary Tract Symptoms (LUTS) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder (OAB) Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

35 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Site 2 - Mercy University Hospital, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vesitirim™ (Solifenacin)

Drug

Oral

Other names: Solifenacin

Primary outcomes

  1. Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score

    Time frame: Baseline and 12 weeks

  2. Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS)

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change from baseline to visit 2 in voiding function assessed by Qmax and PVR

    Time frame: Baseline and 12 weeks

  2. 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

  3. 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

  4. Change from baseline to visit 2 in quality of life assessed by IPSS score

    Time frame: Baseline and 12 weeks

  5. Adverse drug reactions- incidence of acute urinary retention and urinary tract infection

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study title

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

Acronym: VIM

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2012
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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