Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome) (VENICE)
This study is currently recruiting participants.
Verified February 2013 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Europe BV
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier:
NCT01799902
First received: February 25, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lower Urinary Tract Predominant Storage Symptoms |
Drug: Solifenacin |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Change in I-PSS storage scores (frequency, urgency, nocturia) [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Voiding scores (incomplete emptying, intermittency, weak stream and straining) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
- Total and individual I-PSS item scores [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
- Quality Of Life assessed by the patient I-PSS questionnaire [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
- Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
- Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Male subjects with LUT predominant storage symptoms (OAB)
male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination
|
Drug: Solifenacin
Oral
Other Name: YM905, Vesicare®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799902
Contacts
| Contact: Medical Department | +31(0)71 5455 878 | contact@nl.astellas.com |
Locations
| Belgium | |
| AZ Jan-Palfijn | Active, not recruiting |
| Aalst, Belgium, 9300 | |
| ZNA Stuyvenberg | Recruiting |
| Antwerpen, Belgium, 2060 | |
| ZNA Middelheim | Active, not recruiting |
| Antwerpen, Belgium, 2020 | |
| ZNA Jan Palfijn | Active, not recruiting |
| Antwerpen, Belgium, 2170 | |
| Private practice | Active, not recruiting |
| Antwerpen, Belgium, 2018 | |
| Ziekenhuis Maas & kempen | Active, not recruiting |
| Bree, Belgium, 3960 | |
| AZ Sint-Lucas | Withdrawn |
| Brugge, Belgium, 8310 | |
| Erasme | Recruiting |
| Brussel, Belgium, 1070 | |
| UZ Brussel | Recruiting |
| Brussel, Belgium, 1090 | |
| Private practice | Recruiting |
| Brussel, Belgium, 1180 | |
| AZ Sint-Blasius | Active, not recruiting |
| Dendermonde, Belgium, 9200 | |
| AZ St. Monica | Recruiting |
| Deurne, Belgium, 2100 | |
| UZ Antwerpen | Recruiting |
| Edegem, Belgium, 2650 | |
| ZOL Genk | Active, not recruiting |
| Genk, Belgium, 3600 | |
| Maria Middelares | Recruiting |
| Gent, Belgium, 9000 | |
| UZ Gent | Recruiting |
| Gent, Belgium, 9000 | |
| Sint-Lucas | Recruiting |
| Gent, Belgium, 9000 | |
| Sint-Franciskus | Withdrawn |
| Heusden, Belgium, 3550 | |
| Jan Yperman | Active, not recruiting |
| Ieper, Belgium, 8900 | |
| Sint Jozefskliniek | Active, not recruiting |
| Izegem, Belgium, 8870 | |
| AZ Groninge | Active, not recruiting |
| Kortrijk, Belgium, 8500 | |
| Private practice | Recruiting |
| Lasne, Belgium, 1380 | |
| HH Oostende | Recruiting |
| Oostende, Belgium, 8400 | |
| AZ Sint-Jan | Active, not recruiting |
| Oostende, Belgium, 8400 | |
| AZ Oudenaarde | Recruiting |
| Oudenaarde, Belgium, 9700 | |
| Mariaziekenhuis Noord Limburg | Recruiting |
| Overpelt, Belgium, 3900 | |
| H.Hart Roeselaere | Active, not recruiting |
| Roeselaere, Belgium, 8800 | |
| Heilig Hart Ziekenhuis | Active, not recruiting |
| Tienen, Belgium, 3300 | |
| AZ Turnhout | Active, not recruiting |
| Turnhout, Belgium, 2300 | |
| AZ Sint Elisabeth | Completed |
| Zottegem, Belgium, 9620 | |
Sponsors and Collaborators
Astellas Pharma Europe BV
Veeda Clinical Research
Investigators
| Study Director: | Medical Director | Astellas Pharma Europe B.V. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Europe BV ) |
| ClinicalTrials.gov Identifier: | NCT01799902 History of Changes |
| Other Study ID Numbers: | BE-11-VES-01 |
| Study First Received: | February 25, 2013 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Astellas Pharma Inc:
|
Observational Non-Interventional Prospective Phase IV Treatment Overactive Bladder Syndrome Solifenacin |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013