Status:
COMPLETED
Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
Lead Sponsor:
University of Florence
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostat...
Eligibility Criteria
Inclusion
- adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
- treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
- being capable of giving informed consent.
Exclusion
- participation in another clinical study;
- known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value \>10 ng/mL;
- suspected lack of the participant's compliance;
- known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
- nown neurogenic bladder (i.e. Parkinson's disease);
- suspected or proven urinary infections;
- presence of bladder stone.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT02252367
Start Date
December 1 2015
End Date
June 1 2020
Last Update
April 28 2021
Active Locations (1)
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1
Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Florence, Italy