A SINGLE-CENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION THERAPY WITH VARDENAFIL 10 mg AND TAMSULOSIN 0,4 mg IN THE TREATMENT OF MEN WITH PERSISTENT IRRITATIVE URINARY SYMPTOMS - FI.LU.VA

• Conditions: men with persistent irritative urinary symptoms; MedDRA version: 13.1Level: PTClassification code 10005034Term: Bladder discomfortSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2010-022138-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-09
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 40 and 80 years • Men with LUTS and OAB defined by: – IPSS, flow assessment, measurement of post void residual urine – Mean urinary frequency ?8 times /24 hours.Mean number of urgency episodes, with or without urgency incontinence ?1 episode /24 hours. ? With both irritative and obstructive symptoms • Mean voided volume <400 ml as verified by the bladder diary completed prior to randomization • Qmax >5 ml/sec with a voided volume >150 ml • Evidence of a personally signed and dated informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Hypersensitivity to vardenafil or omnic • Drugs with proven or suspected incompatibility with vardenafil or omnic • Bladder failure or Neurogenic bladder • UTI / Prostatitis • LUT disease + LUT treatment • LUT surgery • Severe systemic disease • Unable to consistently and accurately complete the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified