Lower Urinary Tract Predominant Storage Symptoms Clinical Trial
— VENICEOfficial 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
| Verified date | December 2013 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ASZ | Aalst | |
| Belgium | ZNA Stuyvenberg | Antwerpen | |
| Belgium | Erasme | Brussel | |
| Belgium | Private practice | Brussel | |
| Belgium | UZ Brussel | Brussel | |
| Belgium | AZ St. Monica | Deurne | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | Maria Middelares | Gent | |
| Belgium | Sint-Lucas | Gent | |
| Belgium | UZ Gent | Gent | |
| Belgium | AZ Groeninge | Kortrijk | |
| Belgium | AZ Damiaan | Oostende | |
| Belgium | AZ Oudenaarde | Oudenaarde | |
| Belgium | H.Hart Roeselaere | Roeselaere | |
| Belgium | AZ Sint Elisabeth | Zottegem |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Europe B.V. | Veeda Clinical Research |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in I-PSS storage scores (frequency, urgency, nocturia) | To evaluate the effect of solifenacin monotherapy or combination with an a receptor blocker on storage symptoms measured by the patient I-PSS (International Prostate Symptom Score questionnaire) | Baseline, Week 6 and 12 | No |
| Secondary | Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours | Baseline, Week 6 and 12 | No | |
| Secondary | Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours | Baseline, Week 6 and 12 | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Voiding scores (incomplete emptying, intermittency, weak stream and straining) | Week 1, 6 and 12 | No | |
| Secondary | Total and individual I-PSS item scores | Week 1, 6 and 12 | No | |
| Secondary | Quality Of Life assessed by the patient I-PSS questionnaire | Week 1, 6 and 12 | No | |
| Secondary | Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS) | Week 1, 6 and 12 | No | |
| Secondary | Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS) | Week 1, 6 and 12 | No |