Lower Urinary Tract Predominant Storage Symptoms Clinical Trial
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
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective