Clinical trial NCT02252367: Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
Official title: Double-blind, Placebo-controlled Study on Men With Lower Urinary Tract Symptoms to Assess Changes in Pressure Flow Study and in Molecular Profile of Prostatic Tissue After 12 Weeks Treatment With Tadalafil.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Phosphodiesterase 5 Inhibitors
BPH/LUTS
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2014-09-30
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of LUTS/BPH symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement of pressure flow study (PFS) parameters
timeFrame: 12 weeks
measure: Volumetric change of the prostate
timeFrame: 12 weeks
measure: Change in prostate inhomogeneity and in the number of prostatic macrocalcifications
timeFrame: 12 weeks
measure: Variation in genic expression of prostatic inflammation markers
timeFrame: 12 weeks
measure: Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate)
timeFrame: 12 weeks
measure: Improvement in metabolic profile
timeFrame: 12 weeks
measure: Variation in seminal plasma IL-8 (interleukin-8) levels
timeFrame: 12 weeks
measure: Improvement in erectile function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi
Study officials:
affiliation: University of Florence
name: Mario Maggi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gacci M, Corona G, Salvi M, Vignozzi L, McVary KT, Kaplan SA, Roehrborn CG, Serni S, Mirone V, Carini M, Maggi M. A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with alpha-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol. 2012 May;61(5):994-1003. doi: 10.1016/j.eururo.2012.02.033. Epub 2012 Feb 25.
citation: Gacci M, Vittori G, Tosi N, Siena G, Rossetti MA, Lapini A, Vignozzi L, Serni S, Maggi M, Carini M. A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. 2012 Jun;9(6):1624-33. doi: 10.1111/j.1743-6109.2012.02718.x. Epub 2012 Apr 17.