Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

University of Florence (UNIFI)

Status and phase: Completed; Phase 4

Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Treatments: Drug: Tadalafil; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02252367

ANDRO-AOUC-2014-01

Details and patient eligibility

About

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 prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated.

Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

Tadalafil

Experimental group

Description:

43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to tadalafil 5 mg - 1 film-coated tablet orally once daily for 12 weeks.

Treatment:

Drug: Tadalafil

Placebo

Placebo Comparator group

Description:

43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo.

Treatment:

Other: Placebo