Prostate Biopsy
Conditions
Brief summary
This is a post-market clinical investigation evaluating the effect of immersive virtual reality (VR) as an adjunct to standard local anesthesia during transperineal prostate biopsy. Transperineal prostate biopsy under local anesthesia is commonly associated with patient anxiety, procedural discomfort, and vasovagal reactions, which may negatively impact patient experience and procedural tolerability. Non-pharmacological distraction techniques such as immersive VR have shown potential to reduce perceived pain and anxiety during short, invasive medical procedures by modulating cognitive attention and emotional response. This study investigates whether the use of an immersive VR headset, added to standard local anesthesia, can reduce peri-procedural anxiety and pain compared to standard care alone. The intervention is designed to provide continuous audiovisual immersive distraction starting shortly before the procedure and continuing throughout the biopsy, without altering standard clinical workflow or increasing procedural invasiveness. This is a randomized, controlled, parallel-group, 1:1 superiority trial with a single-blind (assessor-blinded) design. Participants undergoing transperineal prostate biopsy under local anesthesia will be randomly assigned to one of two groups: standard local anesthesia alone (control arm) or standard local anesthesia plus immersive VR (experimental arm). The primary objective is to evaluate whether immersive VR reduces peri-procedural anxiety and pain compared with standard local anesthesia alone. Secondary objectives may include evaluation of patient satisfaction, tolerability of the VR intervention, and incidence of vasovagal reactions or procedural interruptions. The study aims to generate evidence on the feasibility and clinical benefit of integrating immersive VR as a non-pharmacological supportive tool in urological diagnostic procedures.
Interventions
PROCEDUREStandard Local Anesthesia
Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied.
DEVICEImmersive Virtual Reality (VR) Headset
Transperineal prostate biopsy performed under standard local anesthesia with the addition of an immersive virtual reality (VR) headset used as a non-pharmacological distraction tool. The VR device is applied approximately 3-5 minutes before the start of the procedure and worn continuously throughout the biopsy.
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participant provides written informed consent for the trial * Male participants who are at least 18 years of age on the day of signing informed consent * Men undergoing transperineal prostate biopsy under local anesthesia
Exclusion criteria
* Visual or hearing impairment that would prevent effective use of the virtual reality device * History of epilepsy or seizure disorders * Severe motion sickness or known susceptibility to cybersickness * Severe psychiatric disorders that, in the investigator's judgment, could interfere with study participation or outcome assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain Intensity | Immediately after completion of the biopsy procedure | Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural anxiety | Immediately post-procedure | Assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1). The STAI-Y1 total score ranges from 20 to 80, with higher scores indicating greater anxiety |
| Decision regret | 1 month (Day 30 ± 5 days) after the procedure | Assessed using the validated Decision Regret Scale (DRS). The Decision Regret Scale is a 5-item questionnaire assessing regret following a healthcare decision. Scores range from 0 to 100, with higher scores indicating greater decision regret. |
| Urinary incontinence | Baseline and 1 month (Day 30 ± 5 days) after the procedure | Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Total scores range from 0 to 21, with higher scores indicating greater severity of urinary incontinence. |
| Lower urinary tract symptoms | Baseline and 1 month (Day 30 ± 5 days) after the procedure | Assessed using the International Prostate Symptom Score (IPSS). Total scores range from 0 to 35, with higher scores indicating greater severity of lower urinary tract symptoms. |
| Sexual function | Baseline and 1 month (Day 30 ± 5 days) after the procedure | Assessed using the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item questionnaire assessing male sexual function. Total scores range from 5 to 75, with higher scores indicating better sexual function. |
| Health-related quality of life | Baseline and 1 month (Day 30 ± 5 days) after the procedure | Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). The EORTC QLQ is a validated questionnaire assessing health-related quality of life. Scores are transformed into a 0 to 100 scale. For functional scales and global health status, higher scores indicate better quality of life, whereas for symptom scales, higher scores indicate greater symptom burden. |
| Depressive symptoms | Baseline and 1 month (Day 30 ± 5 days) after the procedure | Assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire assessing depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms. |
| Post-procedural complications | During the procedure and up to 30 days after the procedure | Collection of all reported complications related to the biopsy procedure, including vasovagal reactions and other adverse events. |
Countries
Italy
Outcome results
None listed