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

Astellas Pharma Europe B.V.86 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lower Urinary Tract Predominant Storage Symptoms

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

ASZ

Aalst, Belgium

ZNA Stuyvenberg

Antwerp, Belgium

Erasme

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Private practice

Brussels, Belgium

AZ St. Monica

Deurne, Belgium

UZ Antwerpen

Edegem, Belgium

Maria Middelares

Ghent, Belgium

Sint-Lucas

Ghent, Belgium

UZ Gent

Ghent, Belgium

...and 5 more locations

Outcomes

Primary Outcomes

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)