Pain Comparison: Transrectal vs. Transperineal Prostate Biopsy

NCT07577895 | Not Yet Recruiting

• 1 other identifier: SBU-URO-AG-04
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

prostat cancer; pain; outpatient urology; pain perception; prostate biopsy

Outcome Measures

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.

  Within 15 minutes after completion of the biopsy procedure

Secondary Outcomes (3)

• Pre-Procedural Anticipated Pain Level

  Within 30 minutes before the biopsy procedure

• Post-Procedural Experienced Pain Level

  From immediately before to immediately after prostate biopsy

• Effect of Age on Pain Perception

  Immediately after prostate biopsy

Study Arms (2)

Transrectal Prostate Biopsy Group

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.

Transperineal Prostate Biopsy Group

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.

Eligibility Criteria

• Gender Eligibility Details: This study includes only male participants because prostate biopsy is performed exclusively in patients with a prostate gland, which is an anatomical structure present only in biological males."
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

Study Sites (1)

Kayseri Education and Research Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pain

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mert Ali Karadağ, Professor

  Kayseri Education and Research Hospital

  STUDY CHAIR

• Abdullah Gölbaşı, Assistant Professor

  Kayseri Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Gölbaşı, Assistant Professor

CONTACT

+90 352 315 77 00; kayserisehir@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)