Lower Urinary Tract Predominant Storage SymptomsVENICENCT01799902
Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
An observational study of Lower Urinary Tract Predominant Storage Symptoms, run by Astellas Pharma Europe B.V. at 15 sites in Belgium.
Trial summary
This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Predominant Storage Symptoms
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- How many people
- 86 participants
- Where
- 15 sitesBelgium
- Study dates
- Dec 2011to Oct 2013
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.
Who may be able to join
- The following subjects can be included in this study if they answer the following 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.
Who cannot join
- Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Belgium15 sites
ASZ
Aalst, 9300
ZNA Stuyvenberg
Antwerp, 2060
Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
Private practice
Brussels, 1180
AZ St. Monica
Deurne, 2100
UZ Antwerpen
Edegem, 2650
Maria Middelares
Ghent, 9000
Sint-Lucas
Ghent, 9000
UZ Gent
Ghent, 9000
AZ Groeninge
Kortrijk, 8500
AZ Damiaan
Ostend, 8400
AZ Oudenaarde
Oudenaarde, 9700
H.Hart Roeselaere
Roeselaere, 8800
AZ Sint Elisabeth
Zottegem, 9620
About this study
Official title: Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination
This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol.
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.
Read more
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.
- Being tested
- Solifenacin
- Keywords
- Observational, Non-Interventional Prospective, Phase IV Treatment, Overactive Bladder Syndrome, Solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Also called YM905, Vesicare®
Oral
| Study group | Role | What they receive |
|---|---|---|
| Male subjects with LUT predominant storage symptoms (OAB) | male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in I-PSS storage scores (frequency, urgency, nocturia)
To evaluate the effect of solifenacin monotherapy or combination with an α receptor blocker on storage symptoms measured by the patient I-PSS (International Prostate Symptom Score questionnaire)
Measured: Baseline, Week 6 and 12
Secondary outcomes (9)
Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours
Measured: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours
Measured: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of urgency (grade 3 or 4, Patient Perception of Intensity of Urgency Scale (PPIUS)) episodes per 24 hours
Measured: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of urge incontinence (grade 4, PPIUS) episodes per 24 hours
Measured: Baseline, Week 6 and 12
Voiding scores (incomplete emptying, intermittency, weak stream and straining)
Measured: Week 1, 6 and 12
Total and individual I-PSS item scores
Measured: Week 1, 6 and 12
Quality Of Life assessed by the patient I-PSS questionnaire
Measured: Week 1, 6 and 12
Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)
Measured: Week 1, 6 and 12
Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)
Measured: Week 1, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Predominant Storage SymptomsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veeda Clinical Research
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799902
- Sponsor's protocol ID
- BE-11-VES-01
- Acronym
- VENICE
- Status last verified
- Dec 2013
- First submitted
- 25 Feb 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Observational Study to Evaluate Storage and Voiding Symptoms Improvement in Male Subjects With Lower Urinary Tract Predominant Storage Symptoms (Overactive Bladder Syndrome) Being Treated With Solifenacin in Monotherapy or Combination
- ClinicalTrials.gov ID
- NCT01799902
- Acronym / sponsor ID
- VENICE / BE-11-VES-01
- Keywords
- Observational, Non-Interventional Prospective, Phase IV Treatment, Overactive Bladder Syndrome, Solifenacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Veeda Clinical Research
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Feb 2013 (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 study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male subjects with LUT predominant storage symptoms (OAB) | – | Drug: Solifenacinmale subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.
Key inclusion criteria (5 listed)
- The following subjects can be included in this study if they answer the following 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.
Key exclusion criteria (3 listed)
- Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
- 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.
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 |
|---|---|---|
| SolifenacinAlso: YM905, Vesicare®Oral | Drug | Male subjects with LUT predominant storage symptoms (OAB) |
Primary outcome
Change in I-PSS storage scores (frequency, urgency, nocturia)
Time frame: Baseline, Week 6 and 12
To evaluate the effect of solifenacin monotherapy or combination with an α receptor blocker on storage symptoms measured by the patient I-PSS (International Prostate Symptom Score questionnaire)
9 secondary outcomes
Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours
Time frame: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours
Time frame: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of urgency (grade 3 or 4, Patient Perception of Intensity of Urgency Scale (PPIUS)) episodes per 24 hours
Time frame: Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of urge incontinence (grade 4, PPIUS) episodes per 24 hours
Time frame: Baseline, Week 6 and 12
Voiding scores (incomplete emptying, intermittency, weak stream and straining)
Time frame: Week 1, 6 and 12
Total and individual I-PSS item scores
Time frame: Week 1, 6 and 12
Quality Of Life assessed by the patient I-PSS questionnaire
Time frame: Week 1, 6 and 12
Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)
Time frame: Week 1, 6 and 12
Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)
Time frame: Week 1, 6 and 12
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 19 Dec 2013.
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 director
Astellas Pharma Europe B.V.
15 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 Predominant Storage Symptoms, run by Astellas Pharma Europe B.V. at 15 sites in Belgium.
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 5 inclusion and 3 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium. 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 in I-PSS storage scores (frequency, urgency, nocturia) (time frame: Baseline, Week 6 and 12). 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 19 Dec 2013.