Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome) (VENICE)
|ClinicalTrials.gov Identifier: NCT01799902|
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : December 19, 2013
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 or disease||Intervention/treatment|
|Lower Urinary Tract Predominant Storage Symptoms||Drug: Solifenacin|
|Study Type :||Observational|
|Actual Enrollment :||86 participants|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Male subjects with LUT predominant storage symptoms (OAB)
male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination
Other Name: YM905, Vesicare®
- 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)
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799902
|Aalst, Belgium, 9300|
|Antwerpen, Belgium, 2060|
|Brussel, Belgium, 1070|
|Brussel, Belgium, 1090|
|Brussel, Belgium, 1180|
|AZ St. Monica|
|Deurne, Belgium, 2100|
|Edegem, Belgium, 2650|
|Gent, Belgium, 9000|
|Gent, Belgium, 9000|
|Gent, Belgium, 9000|
|Kortrijk, Belgium, 8500|
|Oostende, Belgium, 8400|
|Oudenaarde, Belgium, 9700|
|Roeselaere, Belgium, 8800|
|AZ Sint Elisabeth|
|Zottegem, Belgium, 9620|
|Study Director:||Medical Director||Astellas Pharma Europe B.V.|