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

Astellas

Status: Completed

Conditions: Lower Urinary Tract Predominant Storage Symptoms

Treatments: Drug: Solifenacin

Study type: Observational

Funder types: Industry

Identifiers

NCT01799902

BE-11-VES-01

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

86 participants in 1 patient group

Male subjects with LUT predominant storage symptoms (OAB)

Description:

male subjects with Overactive Bladder Syndrome (OAB) being treated with solifenacin in monotherapy or combination

Treatment:

Drug: Solifenacin