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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lower Urinary Tract Symptoms, Voiding Disorders, Pain, Quality of Life

Intervention / Treatment
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* Drug: Tadalafil 5mg
* Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tadalafil<br> | Drug: Tadalafil 5mg<br>* Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy<br>|
| Active Comparator: Tamsulosin<br> | Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule<br>* Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Administration of placebo ( Vitamin C [ascorbic acid] 500mg tablet) once daily seven days before and seven days after prostate biopsy<br>* Other names: Vitamin C (ascorbic acid) 500mg tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analog scale for pain (VAS) | Visual analog scale is a simple scale that rates pain form zero to ten, where zero is rated as no pain and ten is rated as unbearable pain. The patient fills it by putting an X on the lane, where no pain, mild and moderate pain is on the left side of the line and severe, very severe and worst pain possible is on the right side of the line. | Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy | 
| Change in International prostate symptom score ( IPSS/QoL) | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. There is also a separate question regarding quality of life. | Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The short form health survey - SF-36 | SF -36 measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health) | Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy | 
| Change in The International Index of Erectile Function (IIEF-5) Questionnaire | IIEF-5 is a validated questionnaire for erectile function. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Based on equal misclassification rates of erectile disfunction (ED) and no ED, a cutoff score of 21 (range of scores, 5-25) discriminated best. ED was classified into five severity levels, ranging from none (22-25) through severe (5-7). Substantial agreement existed between the predicted and 'true' ED classes. These data suggest that the IIEF-5 possesses favorable properties for detecting the presence and severity of ED. | Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy |