Informed Consent for Transrectal Ultrasound (TRUS) Guided Prostate Biopsy

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Informed Consent for Transrectal Ultrasound (TRUS) Guided Prostate Biopsy

Patient and Facility Information

Nature and Purpose of the Procedure

A transrectal ultrasound (TRUS) guided prostate biopsy is a diagnostic procedure performed to harvest small core tissue samples from the prostate gland for histological examination. It is indicated when there is a clinical suspicion of prostate cancer, such as an elevated Prostate-Specific Antigen (PSA) level or an abnormal digital rectal examination (DRE). The procedure is performed under local anesthesia (typically a periprostatic nerve block) in an outpatient setting. An ultrasound probe is placed into the rectum to visualize the prostate gland and guide the biopsy needle. Using a spring-loaded biopsy gun, the urologist harvests multiple tissue cores (typically 12 cores, targeting different zones of the prostate) through the rectal wall. An MRI-ultrasound fusion technique may be used if a pre-biopsy MRI identified specific suspicious lesions. The procedure takes approximately 15 to 30 minutes.

Antibiotic Prophylaxis Protocol

Because the biopsy needle passes through the rectum into the prostate, there is a risk of introducing bacteria into the prostate and bloodstream. To reduce this risk, you must strictly follow the prescribed antibiotic prophylaxis protocol. This typically involves taking oral antibiotics (such as ciprofloxacin or sulfamethoxazole-trimethoprim) or receiving an intramuscular injection prior to the procedure, and continuing oral antibiotics for 1 to 3 days after. You must inform your urologist immediately if you failed to take your antibiotics as directed prior to the biopsy.

Material Risks and Potential Complications

Sepsis and severe infection: despite antibiotic prophylaxis, severe urinary tract infection or bloodstream infection (sepsis) occurs in approximately 1 to 2 percent of cases. Sepsis is a life-threatening medical emergency requiring immediate hospitalization and intravenous antibiotics. Very rarely, severe perineal soft tissue infections such as Fournier's gangrene can occur.
Hematuria (blood in the urine) and hematochezia (blood in the stool): extremely common after biopsy, occurring in up to 50 to 80 percent of patients. Bleeding is usually mild and resolves spontaneously over 3 to 7 days. You should seek medical attention if you pass large blood clots or cannot empty your bladder.
Hemospermia (blood in the semen): blood or a rust-colored discoloration of the semen is very common, occurring in up to 80 percent of patients, and can persist for 4 to 12 weeks after the procedure. This is harmless and resolves spontaneously.
Acute urinary retention: inability to urinate due to biopsy-induced swelling of the prostate or urethra, occurring in less than 2 percent of cases. This requires temporary placement of a urinary catheter.
Pain and discomfort: mild rectal or perineal discomfort during and for a few days after the procedure, typically managed with over-the-counter acetaminophen.

Expected Benefits

The primary expected benefit of a prostate biopsy is a definitive pathological diagnosis of your prostate condition. This confirms or rules out the presence of prostate adenocarcinoma, identifies the grade of the cancer (Gleason score), and helps guide subsequent management decisions, which range from active surveillance to surgery or radiation.

Reasonable Alternatives to Biopsy

Transperineal prostate biopsy: harvesting tissue cores by passing the needle through the perineal skin (between the scrotum and anus) rather than the rectum, which reduces the risk of fecal bacterial contamination but may require general anesthesia.
Advanced imaging and blood testing: monitoring PSA trends, free PSA ratios, Prostate Health Index (PHI), or performing a multiparametric MRI (mpMRI) of the prostate. These tests help estimate risk but cannot provide a definitive tissue diagnosis.
Observation / Decline biopsy: choosing not to undergo diagnostic testing, accepting the risk that a clinically significant prostate cancer may remain undiagnosed and progress to an incurable stage.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the biopsy begins without penalty or adverse effect on your medical care. Your urologist will discuss the clinical implications of declining the diagnosis.

Questions and Understanding Confirmation

I confirm that I have reviewed this consent form with my urologist. I understand the importance of the antibiotic protocol, the high likelihood of blood in the urine, stool, and semen, and the small but serious risk of sepsis requiring hospitalization. All my questions have been answered.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified medical interpreter is available to you at no cost. Please notify your care team if you require interpreter services before signing this document.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form for my own records. I understand I may request an additional copy at any time from the facility or clinical records department.

Patient Authorization

I have been informed of the transrectal prostate biopsy procedure, its expected benefits, the material risks listed above, and the available alternatives. I consent to proceed with a TRUS-guided prostate biopsy, including the administration of local anesthesia.

Signatures and Verification

Patient / LAR Signature
Urologist Signature
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
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