NCT01799902

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Solifenacin	Oral

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-02-27
• Last updated: 2013-12-19

Locations

15 sites across 1 country: Belgium