NCT05537272

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

A Study Evaluating the Therapeutic Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital of Split · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

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

Detailed description

After being informed about the clinical study and all the risks, all patients will be given a written informed consent. They will be randomised in three groups: A (tadalafil),B (tamsulosin) and C (placebo) and the drug or placebo will be administrated seven days before and seven days after transperineal prostate biopsy. Thirty minutes before the biopsy, all patients will receive a prophylactic antibiotic (ceftriaxone 2g intravenously) and an analgetic ( naklofen 75mg intramuscular injection). Before the biopsy patients will do an uroflowmetry to determine the Qmax and ultrasound(US) of the urinary tract to determine residual urine. After the biopsy is performed the patient fills out the international prostate symptom score (IPSS/QoL), visual analog scale (VAS) for pain, International Index of Erectile Function (IIEF-5) and 36-Item Short Form Survey (SF-36) questionnaires. Seven days after the biopsy the patient discontinues with the therapy and makes a visit for routine control of uroflowmetry, US of the urinary tract and he previously mentioned questionnaires are filled out. After 30 days of the biopsy the patient makes a visit for regular control of the pathohistological findings, uroflowmetry and ultrasound of the urinary tract, along with filling out the questionnaires again.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-09-13
• Last updated: 2023-02-22

Locations

1 site across 1 country: Croatia

Regulatory

• FDA-regulated drug study