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Trial record 7 of 271 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

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

Tracking Information
First Submitted Date  ICMJE September 22, 2014
First Posted Date  ICMJE September 30, 2014
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02252367 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
  • 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.
  • Volumetric change of the prostate [ Time Frame: 12 weeks ]
    Prostate volume as assessed by transrectal ultrasound
  • 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.
  • 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.
  • 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
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • 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.
  • Volumetric change of the prostate [ Time Frame: 12 weeks ]
  • 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.
  • Variation in genic expression of prostatic inflammation markers [ Time Frame: 6 months ]
    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.
  • Variation in serum inflammation markers CRP (C-reactive protein) and ESR (Erythrocyte Sedimentation Rate) [ Time Frame: 6 months ]
  • 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)
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms
Intervention  ICMJE
  • Drug: Tadalafil
    Tadalafil 5 mg once daily for 12 weeks.
    Other Name: Cialis
  • Other: Placebo
    Placebo tablet once daily for 12 weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tadalafil
  • Placebo Comparator: Placebo
    43 male subjects affected by BPH (benign prostatic hyperplasia) planned for simple prostatectomy will be randomized to placebo.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2014)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mario Maggi m.maggi@dfc.unifi.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252367
Other Study ID Numbers  ICMJE ANDRO-AOUC-2014-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Maggi, University of Florence
Study Sponsor  ICMJE University of Florence
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Mario Maggi University of Florence
PRS Account University of Florence
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP