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
• Sponsor: Astellas Pharma Europe B.V.
• Collaborator: Veeda Clinical Research
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Tracking Information

• First Submitted Date: February 25, 2013
• First Posted Date: February 27, 2013
• Last Update Posted Date: December 19, 2013
• Study Start Date: December 2011
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2013)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 25, 2013)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)
• 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Lower Urinary Tract Predominant Storage Symptoms

Intervention

Drug: Solifenacin

Oral

Other Name: YM905, Vesicare®

Study Groups/Cohorts

Male subjects with LUT predominant storage symptoms (OAB)

male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination

Intervention: Drug: Solifenacin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2013): 86
• Original Estimated Enrollment (submitted: February 25, 2013): 250
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01799902
• Other Study ID Numbers: BE-11-VES-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
• Study Sponsor: Astellas Pharma Europe B.V.
• Collaborators: Veeda Clinical Research

Investigators

• Study Director: Medical Director; Astellas Pharma Europe B.V.

• PRS Account: Astellas Pharma Inc
• Verification Date: December 2013