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

NCT02252367 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

  • Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Interventions

DRUG

Tadalafil

Tadalafil 5 mg once daily for 12 weeks.

OTHER

Placebo

Placebo tablet once daily for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Mario Maggi · University of Florence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-01-31
Completion
2020-06-30

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252367 on ClinicalTrials.gov