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

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ClinicalTrials.gov Identifier: NCT02252367
Recruitment Status : Recruiting
First Posted : September 30, 2014
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Mario Maggi, 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.


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Lower Urinary Tract Symptoms Drug: Tadalafil Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Experimental: 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.
Drug: Tadalafil
Tadalafil 5 mg once daily for 12 weeks.
Other Name: Cialis

Placebo Comparator: Placebo
43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo.
Other: Placebo
Placebo tablet once daily for 12 weeks.




Primary Outcome Measures :
  1. Improvement of LUTS/BPH symptoms [ Time Frame: 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 :
  1. Improvement of pressure flow study (PFS) parameters [ Time Frame: 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.

  2. Volumetric change of the prostate [ Time Frame: 12 weeks ]
    Prostate volume as assessed by transrectal ultrasound

  3. Change in prostate inhomogeneity and in the number of prostatic macrocalcifications [ Time Frame: 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.

  4. Variation in genic expression of prostatic inflammation markers [ Time Frame: 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.

  5. Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate) [ Time Frame: 12 weeks ]
    CRP measured on serum and ESR measured on blood drawn at baseline and after 12 weeks

  6. Improvement in metabolic profile [ Time Frame: 12 weeks ]
    Metabolic parameters will be evaluated (glycaemia, insulinemia, total cholesterol, HDL, triglycerides, HbA1c, mean arterial pressure, waist circumference, body mass index)

  7. Variation in seminal plasma IL-8 (interleukin-8) levels [ Time Frame: 12 weeks ]
    Seminal IL-8, a chemokine involved in male genital tract infection/inflammation, will be evaluated.

  8. Improvement in erectile function [ Time Frame: 12 weeks ]
    Erectile function will be assessed by using the International Index of Erectile Function-5 (IIEF-5) score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252367


Contacts
Contact: Mario Maggi m.maggi@dfc.unifi.it

Locations
Italy
Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi Recruiting
Florence, Italy
Contact: Mario Maggi       m.maggi@dfc.unifi.it   
Sub-Investigator: Mauro Gacci         
Sub-Investigator: Linda Vignozzi         
Sub-Investigator: Marco Carini         
Sponsors and Collaborators
University of Florence
Eli Lilly and Company
Investigators
Principal Investigator: Mario Maggi University of Florence

Publications:
Responsible Party: Mario Maggi, Full Professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02252367     History of Changes
Other Study ID Numbers: ANDRO-AOUC-2014-01
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Mario Maggi, University of Florence:
Phosphodiesterase 5 Inhibitors
BPH/LUTS

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms
Tadalafil
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents