Lower Urinary Tract Symptoms (LUTS)VIMNCT01639794
Vesitirim™ in Men Postmarketing Observational Study
An observational study of Lower Urinary Tract Symptoms (LUTS) and Overactive Bladder (OAB), run by Astellas Pharma Europe Ltd. at 5 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms (LUTS), Overactive Bladder (OAB)
- What is being tested?
- Vesitirim™ (Solifenacin)
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 5 sitesIreland
- Study dates
- Feb 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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 )
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Site 2 - Mercy University Hospital
Cork
Site: 4 - Tallaght Hospital
Dublin, 24
Site: 1 - St James Hopsital
Dublin, 8
Site: 5 - Beaumont Hospital
Dublin, 9
Site: 3 - Sligo General Hospital
Sligo
About this study
Official title: 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.
Read the 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.
- Being tested
- Vesitirim™ (Solifenacin)
- Keywords
- LUTS (Lower Urinary Tract Symptoms), Overactive Bladder (OAB)Vesitirim, Solifenacin, Anti-muscarinic treatment, Cholinergic receptor antagonist, Storage Symptom improvement
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vesitirim™ (Solifenacin)Drug
Also called Solifenacin
Oral
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Vesitirim™ (Solifenacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score
Measured: Baseline and 12 weeks
Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS)
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change from baseline to visit 2 in voiding function assessed by Qmax and PVR
Measured: 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
Measured: 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
Measured: Baseline and 12 weeks
Change from baseline to visit 2 in quality of life assessed by IPSS score
Measured: Baseline and 12 weeks
Adverse drug reactions- incidence of acute urinary retention and urinary tract infection
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms (LUTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Astellas Pharma Co. Ltd (APCL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639794
- Sponsor's protocol ID
- VES-IE-001
- Acronym
- VIM
- Status last verified
- Jan 2013
- First submitted
- 11 Jul 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Irish Observational Study to Evaluate LUTS Storage Symptom Improvement in Men Being Treated With Vesitirim™ (Solifenacin)
- ClinicalTrials.gov ID
- NCT01639794
- Acronym / sponsor ID
- VIM / VES-IE-001
- Keywords
- LUTS (Lower Urinary Tract Symptoms), Overactive Bladder (OAB)Vesitirim, Solifenacin, Anti-muscarinic treatment, Cholinergic receptor antagonist, Storage Symptom improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male patients with non-neurogenic LUTS taking VESITRIM | – | Drug: Vesitirim™ (Solifenacin)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) |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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 )
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vesitirim™ (Solifenacin)Also: SolifenacinOral | Drug | Male patients with non-neurogenic LUTS taking VESITRIM |
Primary outcome
Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score
Time frame: Baseline and 12 weeks
Change from baseline to visit 2 in patient assessment of treatment satisfaction (TS-VAS)
Time frame: Baseline and 12 weeks
5 secondary outcomes
Change from baseline to visit 2 in voiding function assessed by Qmax and PVR
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks
Change from baseline to visit 2 in quality of life assessed by IPSS score
Time frame: Baseline and 12 weeks
Adverse drug reactions- incidence of acute urinary retention and urinary tract infection
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study chair
Astellas Pharma Co. Ltd (APCL)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms (LUTS) and Overactive Bladder (OAB), run by Astellas Pharma Europe Ltd. at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to visit 2 in Over Active Bladder questionnaire Short Form (OAB-q SF) score (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.