Pain Comparison: Transrectal vs. Transperineal Prostate Biopsy
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorKayseri Education and Research Hospital
About this trial
Prostate biopsy remains the gold standard for the diagnosis of prostate cancer and is most commonly performed using either the transrectal or transperineal approach. Although both techniques offer acceptable diagnostic accuracy, the pain experienced during and after the procedure is an important factor influencing the choice of biopsy approach and overall patient comfort. Pain perception in prostate biopsy is multifactorial, depending on the biopsy route, the number of needle insertions, the local anesthesia protocol, and the innervation of the relevant anatomical structures. The aim of this prospective study is to compare anticipated (pre-procedural expected) and experienced (post-procedural actual) pain levels in patients undergoing transrectal versus transperineal prostate biopsy, using the Visual Analog Scale (VAS). Findings are expected to contribute to clinical decision-making regarding biopsy approach selection with a focus on patient comfort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 18 years and older Patients with clinical indication for prostate biopsy (elevated serum prostate-specific antigen [PSA] level, abnormal digital rectal examination [DRE], and/or suspicious lesion on multiparametric prostate magnetic resonance imaging [mpMRI])
Patients undergoing prostate biopsy for the first time
Patients able to understand and complete the Visual Analog Scale (VAS) for pain assessment
Patients who have provided written informed consent to participate in the study
Disqualifiers
Patients with a history of previous prostate biopsy
Patients with a previously confirmed diagnosis of prostate cancer
Patients with active urinary tract infection or prostatitis at the time of biopsy
Patients with anorectal pathology that may interfere with the transrectal approach (e.g., anal stenosis, active hemorrhoidal disease, anal fissure, prior rectal surgery)
Trial population
The study population consists of male patients with a clinical indication for prostate biopsy, including elevated serum prostate-specific antigen (PSA) levels, abnormal findings on digital rectal examination (DRE), and/or suspicious lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI). Patients will be recruited consecutively from the urology outpatient clinic and will undergo prostate biopsy via either the transrectal or transperineal approach. Only patients undergoing prostate biopsy for the first time, who are able to understand and complete the Visual Analog Scale (VAS) for pain assessment, and who provide written informed consent will be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Transrectal Prostate Biopsy Group
Group B: Transperineal Prostate Biopsy Group
Trial outcomes
Primary outcomes
1
Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups
Experienced pain (perceived immediately after the procedure) will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable). Post-procedural VAS scores will be compared between the transrectal and transperineal prostate biopsy groups.
Time frame
Within 15 minutes after completion of the biopsy procedureSecondary outcomes
1
Pre-Procedural Anticipated Pain Level
Anticipated pain level assessed immediately before the procedure using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable).
Time frame
Within 30 minutes before the biopsy procedure2
Post-Procedural Experienced Pain Level
Experienced pain level assessed immediately after the procedure using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst pain imaginable).
Time frame
From immediately before to immediately after prostate biopsy3
Effect of Age on Pain Perception
Association between patient age and post-procedural experienced pain intensity during prostate biopsy.
Time frame
Immediately after prostate biopsySponsors and contacts
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Source ClinicalTrials.gov
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