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

Phase 4

• Conditions: Pain; Lower Urinary Tract Symptoms; Voiding Disorders; Quality of Life
• Interventions: Drug: Tadalafil 5mg; Drug: Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule; Other: Placebo

• Registration Number: NCT05537272
• Lead Sponsor: University Hospital of Split

Brief 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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-11
• Study First Posted: 2022-09-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tadalafil	Tadalafil 5mg	-
Tamsulosin	Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Visual analog scale for pain (VAS)	Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy	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.
Change in International prostate symptom score ( IPSS/QoL)	Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy	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.

Secondary Outcome Measures

Name	Time	Method
Change in The short form health survey - SF-36	Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy	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)
Change in The International Index of Erectile Function (IIEF-5) Questionnaire	Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy	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.

Trial Locations

Locations (1)

University hospital of Splity; 🇭🇷 Split, Splitsko-dalmatinska, Croatia