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

University Hospital of Split

Status and phase: Invitation-only; Phase 4

Conditions: Lower Urinary Tract Symptoms; Quality of Life; Pain; Voiding Disorders

Treatments: Other: Placebo; Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule; Drug: Tadalafil 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05537272

UHSplit

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Every patient that is a candidate for first time prostate biopsy

Exclusion criteria

• previous complaints of the lower urinary tract; benign prostatic hyperplasia(BPH), overactive bladder (OAB), etc.
• previous urinary retention and catheterization
• previous prostate biopsies
• patients who were treated surgically or medically for BPH
• systemic diseases including uncontrolled diabetes
• neurological diseases
• hemorrhagic diathesis
• patients on anticoagulants therapy
• patients with urinary infections

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Tadalafil

Active Comparator group

Treatment:

Drug: Tadalafil 5mg

Tamsulosin

Active Comparator group

Treatment:

Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule

Placebo

Placebo Comparator group

Treatment:

Other: Placebo