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

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Predominant Storage Symptoms
• Intervention / Treatment: Drug: Solifenacin

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • ASZ
  • Antwerpen, Belgium, 2060
    • ZNA Stuyvenberg
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Brussel, Belgium, 1070
    • Erasme
  • Brussel, Belgium, 1180
    • Private Practice
  • Deurne, Belgium, 2100
    • AZ St. Monica
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • UZ Gent
  • Gent, Belgium, 9000
    • Maria Middelares
  • Gent, Belgium, 9000
    • Sint-Lucas
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Oudenaarde, Belgium, 9700
    • AZ Oudenaarde
  • Roeselaere, Belgium, 8800
    • H.Hart Roeselaere
  • Zottegem, Belgium, 9620
    • AZ Sint Elisabeth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: YM905, Vesicare®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in I-PSS storage scores (frequency, urgency, nocturia)	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)	Baseline, Week 6 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Storage symptoms assessed in the patient bladder diary by Mean number of micturitions per 24 hours	Baseline, Week 6 and 12
Change in Storage symptoms assessed in the patient bladder diary by Mean number of incontinence episodes per 24 hours	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	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	Baseline, Week 6 and 12
Voiding scores (incomplete emptying, intermittency, weak stream and straining)	Week 1, 6 and 12
Total and individual I-PSS item scores	Week 1, 6 and 12
Quality Of Life assessed by the patient I-PSS questionnaire	Week 1, 6 and 12
Treatment satisfaction and treatment benefit for investigator using a visual analogue scale (VAS)	Week 1, 6 and 12
Treatment satisfaction and treatment benefit for patient using a visual analogue scale (VAS)	Week 1, 6 and 12

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.
• Collaborators: Veeda Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (ESTIMATE): February 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Observational; Solifenacin; Overactive Bladder Syndrome; Non-Interventional Prospective; Phase IV Treatment
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: BE-11-VES-01