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NCT Number: NCT02252367

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

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Clinica Urologica - Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil

Drug

Tadalafil 5 mg once daily for 12 weeks.

Other names: Cialis

Placebo

Other

Placebo tablet once daily for 12 weeks.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Sep 30, 2014
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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