Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome) (VENICE)
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| ClinicalTrials.gov Identifier: NCT01799902 |
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Recruitment Status :
Completed
First Posted : February 27, 2013
Last Update Posted : December 19, 2013
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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 |
| 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 |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Male subjects with LUT predominant storage symptoms (OAB)
male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination
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Drug: Solifenacin
Oral
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799902
| Belgium | |
| ASZ | |
| Aalst, Belgium, 9300 | |
| ZNA Stuyvenberg | |
| Antwerpen, Belgium, 2060 | |
| Erasme | |
| Brussel, Belgium, 1070 | |
| UZ Brussel | |
| Brussel, Belgium, 1090 | |
| Private practice | |
| Brussel, Belgium, 1180 | |
| AZ St. Monica | |
| Deurne, Belgium, 2100 | |
| UZ Antwerpen | |
| Edegem, Belgium, 2650 | |
| Maria Middelares | |
| Gent, Belgium, 9000 | |
| Sint-Lucas | |
| Gent, Belgium, 9000 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| AZ Groeninge | |
| Kortrijk, Belgium, 8500 | |
| AZ Damiaan | |
| Oostende, Belgium, 8400 | |
| AZ Oudenaarde | |
| Oudenaarde, Belgium, 9700 | |
| H.Hart Roeselaere | |
| Roeselaere, Belgium, 8800 | |
| AZ Sint Elisabeth | |
| Zottegem, Belgium, 9620 | |
| Study Director: | Medical Director | Astellas Pharma Europe B.V. |
| Responsible Party: | Astellas Pharma Europe B.V. |
| ClinicalTrials.gov Identifier: | NCT01799902 |
| Other Study ID Numbers: |
BE-11-VES-01 |
| First Posted: | February 27, 2013 Key Record Dates |
| Last Update Posted: | December 19, 2013 |
| Last Verified: | December 2013 |
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Observational Non-Interventional Prospective Phase IV Treatment Overactive Bladder Syndrome Solifenacin |
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Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Solifenacin Succinate Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |