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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
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : December 19, 2013
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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