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

NCT01799902 | Completed

• 1 other identifier: BE-11-VES-01
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 15

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.

Conditions

Lower Urinary Tract Predominant Storage Symptoms

Keywords

Observational; Non-Interventional Prospective; Phase IV Treatment; Overactive Bladder Syndrome; Solifenacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

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

Interventions

Solifenacin DRUG

Oral

Also known as: YM905, Vesicare®

Male subjects with LUT predominant storage symptoms (OAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead
• Veeda Clinical Research: collaborator

Study Sites (15)

ASZ

Aalst, 9300, Belgium

Location

ZNA Stuyvenberg

Antwerp, 2060, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Private practice

Brussels, 1180, Belgium

Location

AZ St. Monica

Deurne, 2100, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Maria Middelares

Ghent, 9000, Belgium

Location

Sint-Lucas

Ghent, 9000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

AZ Oudenaarde

Oudenaarde, 9700, Belgium

Location

H.Hart Roeselaere

Roeselaere, 8800, Belgium

Location

AZ Sint Elisabeth

Zottegem, 9620, Belgium

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

BE (15)