Clinical trial NCT05537272: The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Voiding Disorders
Pain
Quality of Life
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual analog scale for pain (VAS)
timeFrame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy
measure: Change in International prostate symptom score ( IPSS/QoL)
timeFrame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy
Secondary outcomes:
measure: Change in The short form health survey - SF-36
timeFrame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy
measure: Change in The International Index of Erectile Function (IIEF-5) Questionnaire
timeFrame: Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy, Time frame 3: 30 days after prostate biopsy
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University hospital of Splity
state: Splitsko-dalmatinska
Study officials:
affiliation: University Hospital Split,Department of Urology
name: Ivo Juginović
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Split,Department of Urology
name: Marijan Šitum
role: STUDY_DIRECTOR
affiliation: University Hospital Split, Department of Anesthesiology and Intensive Care
name: Sandro Glumac
role: STUDY_DIRECTOR
affiliation: University Hospital Split,Department of Urology
name: Mario Duvnjak
role: STUDY_CHAIR
affiliation: University Hospital Split,Department of Urology
name: Marin Jelavić
role: STUDY_CHAIR
affiliation: University Hospital Split, Department of Anesthesiology and Intensive Care
name: Ruben Kovač
role: STUDY_CHAIR
References:
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citation: Bozlu M, Ulusoy E, Doruk E, Cayan S, Canpolat B, Schellhammer PF, Akbay E. Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology. 2003 Dec;62(6):1050-3. doi: 10.1016/j.urology.2003.07.006.
citation: Murray KS, Bailey J, Zuk K, Lopez-Corona E, Thrasher JB. A prospective study of erectile function after transrectal ultrasonography-guided prostate biopsy. BJU Int. 2015 Aug;116(2):190-5. doi: 10.1111/bju.13002. Epub 2015 Mar 23.