Study on the effect of 12 weeks of treatment with tadalafil in patients with symptoms of lower urinary tract secondary to hypertrophy of the prostate.

Phase 1

• Conditions: lower urinary tract symptoms/benign prostatic hyperplasia; MedDRA version: 17.1Level: PTClassification code 10071289Term: Lower urinary tract symptomsSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 17.1Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2014-004422-17-IT
• Lead Sponsor: IVERSITY OF FLORENCE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-19
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

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.
18 Years and older

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

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.

Study & Design

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