NCT07683182Active, not recruiting
Intraprostatic Anesthesia During Transperineal Prostate Biopsy
The Effect of Intraprostatic Local Anesthesia on Pain Perception During Transperineal Prostate Biopsy Under Local Anesthesia
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
Transperineal prostate biopsy has become the standard method for diagnosing prostate cancer because of its favorable safety profile and low infectious complication rates. However, pain and discomfort during the procedure remain important concerns that may negatively affect patient satisfaction and willingness to undergo repeat biopsy when necessary. This prospective randomized controlled study aims to evaluate whether the addition of intraprostatic local anesthesia to standard perineal local anesthesia reduces pain during transperineal prostate biopsy. Fifty patients undergoing prostate biopsy under local anesthesia will be randomized into two groups. The first group will receive standard perineal local anesthesia, while the second group will receive additional intraprostatic local anesthesia. Pain severity will be assessed before, during, and after the procedure using a visual analog scale (VAS). Anxiety and depression levels will be evaluated preoperatively using the Hospital Anxiety and Depression Scale (HADS). Patient-related factors, procedural characteristics, and post-procedural outcomes will also be recorded to identify factors associated with pain perception. The results of this study may help optimize local anesthesia techniques and improve patient comfort during transperineal prostate biopsy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Jun 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Marmara University
- Diseases
- Prostate cancer
- NCT number
- NCT07683182
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Nov 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of prostate biopsy
Other illness
- Known hypersensitivity or contraindication to local anesthetic agents
- Hematological disorders affecting coagulation
- Active urinary tract infection
- Neurological disorders that may affect pain perception
- Psychiatric disorders that may affect pain assessment or completion of study -questionnaires
Other
- Inability to complete the HADS questionnaire or VAS assessment
- Refusal to participate or inability to provide informed consent
Who the study is looking for
- Male patients aged 18 years or older
- Clinical indication for transperineal prostate biopsy based on elevated prostate-specific antigen (PSA) level and/or suspicious digital rectal examination findings
- Ability to understand and complete the Hospital Anxiety and Depression Scale (HADS)
- Ability to provide pain scores using a 10-point Visual Analog Scale (VAS)
- Provision of written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marmara University School of Medicine Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.