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

Phase 4

Completed

• Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia
• Interventions: Other: Placebo; Drug: Tadalafil

• Registration Number: NCT02252367
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Study Start: 2015-12
• Primary Completion: 2019-01
• Study Completion: 2020-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• 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.

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
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement of LUTS/BPH symptoms	12 weeks	BPH-associated inflammatory symptoms will be assessed by using the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI). BPH-associated LUTS will be assessed by using International Prostate Symptom Score (IPSS).

Secondary Outcome Measures

Name	Time	Method
Variation in genic expression of prostatic inflammation markers	12 weeks	BPH-associated prostate inflammation, fibrosis, and hypoxia will be measured by immunohistochemical and quantitative RT-PCR (qRT-PCR) analyses of inflammatory-, fibrosis- and hypoxia-related markers.
Change in prostate inhomogeneity and in the number of prostatic macrocalcifications	12 weeks	BPH-associated prostate inhomogeneity and presence of micro-calcifications will be assessed by using male genital tract male genital tract colour-Doppler ultrasonography.
Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate)	12 weeks	CRP measured on serum and ESR measured on blood drawn at baseline and after 12 weeks
Variation in seminal plasma IL-8 (interleukin-8) levels	12 weeks	Seminal IL-8, a chemokine involved in male genital tract infection/inflammation, will be evaluated.
Volumetric change of the prostate	12 weeks	Prostate volume as assessed by transrectal ultrasound
Improvement in metabolic profile	12 weeks	Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index)
Improvement in erectile function	12 weeks	Erectile function will be assessed by using the International Index of Erectile Function-5 (IIEF-5) score.
Improvement of pressure flow study (PFS) parameters	12 weeks	Maximum flow rate (Qmax), average flow rate (Qave), voided volume (Vcomp), post void residual volume (PVR) will be evaluated. An abdominal ultrasound immediately after voiding for uroflowmetry will be performed in order to determine the PVR.

Trial Locations

Locations (1)

Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy