Clinical trial · Observational
Pain Comparison: Transrectal vs. Transperineal Prostate Biopsy
Comparison of Anticipated and Experienced Pain Levels in Transrectal Versus Transperineal Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Transrectal Prostate Biopsy Group
- description
- Patients in this group will undergo prostate biopsy via the transrectal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the rectal wall under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy.
- label
- Transperineal Prostate Biopsy Group
- description
- Patients in this group will undergo prostate biopsy via the transperineal approach. Prior to the procedure, periprostatic nerve block will be performed as the standard local anesthesia protocol. The biopsy needle will be introduced through the perineal skin under transrectal ultrasound (TRUS) guidance to obtain prostate tissue samples. Anticipated pain will be assessed using the Visual Analog Scale (VAS) before the procedure, after the patient has been informed about both biopsy techniques. Experienced pain will be assessed with the VAS as a single measurement immediately after completion of the biopsy.
Primary outcomes (1)
- measure
- Comparison of Experienced Pain Scores Between Transrectal and Transperineal Prostate Biopsy Groups
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Patients with perineal pathology that may interfere with the transperineal approach (e.g., perineal infection, scarring, or prior surgery) * Patients with bleeding diathesis or those receiving anticoagulant therapy that cannot be safely discontinued before the procedure * Patients with known allergy or hypersensitivity to local anesthetic agents * Patients with chronic pain syndromes or those receiving regular analgesic or opioid treatment that may affect pain perception * Patients with cognitive impairment, psychiatric disorders, or language barriers preventing reliable use of the Visual Analog Scale (VAS) * Patients who refuse to participate or do not provide informed consent
References
Publications (0)
Data not yet available