Intraprostatic Anesthesia During Transperineal Prostate Biopsy
Turkey (Türkiye)50 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Previous history of prostate biopsy
* 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
* Inability to complete the HADS questionnaire or VAS assessment
* Refusal to participate or inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.