Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Veeda Clinical Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male subjects with LUT predominant storage symptoms (OAB) | male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, Week 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours | Baseline, Week 6 and 12 | |
| Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours |
Not provided
Inclusion Criteria:
The following subjects can be included in this study if they answer the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Male patients in Belgium with lower urinary tract predominant storage symptoms (Overactive Bladder Syndrome) being treated with solifenacin in monotherapy or combination.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ | Aalst | 9300 | Belgium | |||
| ZNA Stuyvenberg |
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | Baseline, Week 6 and 12 |
| Voiding scores (incomplete emptying, intermittency, weak stream and straining) | Week 1, 6 and 12 |
| Total and individual I-PSS item scores | Week 1, 6 and 12 |
| Quality Of Life assessed by the patient I-PSS questionnaire | Week 1, 6 and 12 |
| Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS) | Week 1, 6 and 12 |
| Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS) | Week 1, 6 and 12 |
| Antwerp |
| 2060 |
| Belgium |
| Erasme | Brussels | 1070 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Private practice | Brussels | 1180 | Belgium |
| AZ St. Monica | Deurne | 2100 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Maria Middelares | Ghent | 9000 | Belgium |
| Sint-Lucas | Ghent | 9000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| AZ Damiaan | Ostend | 8400 | Belgium |
| AZ Oudenaarde | Oudenaarde | 9700 | Belgium |
| H.Hart Roeselaere | Roeselaere | 8800 | Belgium |
| AZ Sint Elisabeth | Zottegem | 9620 | Belgium |
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided