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The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy

NCT05537272 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the therapeutic efficacy of tamsulosin and tadalafil compared to placebo in the treatment and prevention of urinary disorders after transperineal prostate biopsy

Conditions

  • Lower Urinary Tract Symptoms
  • Voiding Disorders
  • Pain
  • Quality of Life

Interventions

DRUG

Tadalafil 5mg

Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy

DRUG

Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule

Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy

OTHER

Placebo

Administration of placebo ( Vitamin C \[ascorbic acid\] 500mg tablet) once daily seven days before and seven days after prostate biopsy

Sponsors & Collaborators

  • University Hospital of Split

    lead OTHER

Principal Investigators

  • Ivo Juginović · University Hospital Split,Department of Urology

  • Marijan Šitum · University Hospital Split,Department of Urology

  • Sandro Glumac · University Hospital Split, Department of Anesthesiology and Intensive Care

  • Mario Duvnjak · University Hospital Split,Department of Urology

  • Marin Jelavić · University Hospital Split,Department of Urology

  • Ruben Kovač · University Hospital Split, Department of Anesthesiology and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05537272 on ClinicalTrials.gov