Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
NCT ID: NCT01799902
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
86 participants
OBSERVATIONAL
2011-12-31
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
After standard evaluation the investigator will decide the treatment strategy and upon eligibility criteria met will propose subject to participate to the study. Informed consent will be collected for all subjects.
The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow up).
During all observational visits (V1, V2 and V3) the patient will complete the I-PSS (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL) questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual Analogue Scale (VAS).
The patient will be asked to complete a voiding diary the first 3 days after Visit 1 (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.
Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and Trans Rectal Ultra Sound data will be collected only if available.
During all observational visits (V1, V2 and V3) the investigator will complete the assessment of treatment benefit and satisfaction using a VAS.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Male subjects with LUT predominant storage symptoms (OAB)
male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination
Solifenacin
Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Solifenacin
Oral
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC).
* Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator.
* IPSS storage sub-score \> 8
* Subject expected to require at least 3 months treatment with solifenacin.
Exclusion Criteria
* History of bladder obstruction not being adequately corrected.
* Anticipate or plan to participate in another study during study period of 12 weeks from study entry.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Veeda Clinical Research
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASZ
Aalst, , Belgium
ZNA Stuyvenberg
Antwerp, , Belgium
Erasme
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Private practice
Brussels, , Belgium
AZ St. Monica
Deurne, , Belgium
UZ Antwerpen
Edegem, , Belgium
Maria Middelares
Ghent, , Belgium
Sint-Lucas
Ghent, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
AZ Damiaan
Ostend, , Belgium
AZ Oudenaarde
Oudenaarde, , Belgium
H.Hart Roeselaere
Roeselaere, , Belgium
AZ Sint Elisabeth
Zottegem, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BE-11-VES-01
Identifier Type: -
Identifier Source: org_study_id