Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome) (VENICE)

This study has been completed.
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01799902
First received: February 25, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
Lower Urinary Tract Predominant Storage Symptoms
Drug: Solifenacin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in I-PSS storage scores (frequency, urgency, nocturia) [ Time Frame: Baseline, Week 6 and 12 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Voiding scores (incomplete emptying, intermittency, weak stream and straining) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Total and individual I-PSS item scores [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Quality Of Life assessed by the patient I-PSS questionnaire [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS) [ Time Frame: Week 1, 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Male subjects with LUT predominant storage symptoms (OAB)
male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination
Drug: Solifenacin
Oral
Other Name: YM905, Vesicare®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799902

Locations
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
UZ Gent
Gent, Belgium, 9000
Sint-Lucas
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
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Veeda Clinical Research
Investigators
Study Director: Medical Director Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01799902     History of Changes
Other Study ID Numbers: BE-11-VES-01
Study First Received: February 25, 2013
Last Updated: December 18, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Astellas Pharma Inc:
Observational
Non-Interventional Prospective
Phase IV Treatment
Overactive Bladder Syndrome
Solifenacin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Syndrome
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Disease
Pathologic Processes
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014