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Clinical trial

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

ID
Name
UHSplit
Description
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
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-09-01
Trial end
2023-09-01
Phase
Early phase I
Treatment
Tadalafil 5mg
Administration of Tadalafil 5mg once daily seven days before and seven days after prostate biopsy
Arms:
Tadalafil
Tamsulosin Hydrochloride 400 Microgram Prolonged-Release Oral Capsule
Administration of Tamsulosin 0.4mg once daily seven days before and seven days after prostate biopsy
Arms:
Tamsulosin
Placebo
Administration of placebo ( Vitamin C \[ascorbic acid\] 500mg tablet) once daily seven days before and seven days after prostate biopsy
Arms:
Placebo
Other names:
Vitamin C (ascorbic acid) 500mg tablets
Size
120
Primary endpoint
Change in Visual analog scale for pain (VAS)
Time Frame 1: right after prostate biopsy, Time Frame 2: seven days after prostate biopsy
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-02-22

1 organization

2 products

4 indications

Organization
University Hospital of Split
Product
Tadalafil
Indication
Lower Urinary Tract Symptoms
Indication
Voiding Disorders
Indication
Pain
Indication
Quality of Life
Product
Tamsulosin Hydrochloride