Patient Consent form – Prolieve Thermodilatation System Treatment

Patient Consent Form
Prolieve Thermodilatation System Treatment
for the Treatment of Benign Prostatic Hyperplasia (BPH)
I, ___________________________, hereby authorize Triangle Urology Associates, P.A.
(“TUA”) to provide treatment with the Prolieve Thermodilatation System. I understand
that the Prolieve System is a transurethral microwave therapy device that provides a nonsurgical, minimally invasive procedure for the treatment of symptomatic Benign Prostatic
Hyperplasia (BPH). The treatment will take place at TUA’s Durham office on
My doctor has described the treatment process to me. I have also read The Prolieve
System Patient Information Brochure provided to me by my doctor. I understand that the
treatment will take approximately 45 minutes, not including preparation time. The
treatment uses a balloon type catheter inserted into the urethra (the canal that carries urine
from the bladder to the outside of the body) and a temperature monitor inserted into the
rectum. The device uses a combination treatment of compression of the wall of the
urethra (the canal that carries urine from the bladder to the outside of the body) together
with heat applied to the prostate area near the urethral wall using microwave energy (a
method that heats quickly using high frequency electromagnetic radiation). The Prolieve
device heats the prostatic tissue to a temperature between 41C- 46C (106F -115F).
For your safety, the Prolieve System’s computer monitors the temperature surrounding
the treatment area by means of a rectal temperature monitor.
I understand the risks associated with microwave thermotherapy treatments, including
discomfort, bleeding, burning and pressure sensations in the urethra and anal irritation
within six hours of the procedure. Bladder spasms (sharp bladder contractions) may
occur during or after the study treatment, and may cause urinary incontinence (loss of
control of urination). Urination may occasionally be painful. There is a chance you may
need a catheter. The catheter will let urine drain from your bladder while the swelling, if
any goes down. In most cases the catheter will need to remain in for 3 days or less.
These side effects usually disappear shortly after the treatment has been completed and
can be eased with medication. Urinary tract infection or narrowing of the penile urinary
tube may occur at any time after the study treatment.
Other side effects may be infertility (inability to father children), retrograde ejaculation
(semen flowing back into the bladder at orgasm), erectile dysfunction (inability to
maintain an erection or complete intercourse), and impotence (inability to achieve an
erection). In addition, urinary clot retention (inability to void due to blood clots), urethral
stricture (narrowing of the urethral opening), complete urinary retention (inability to
void), incomplete urinary retention, urethral injury, chronic pain at site, pelvic abscess (a
boil in the pelvis), anal irritation, prostatitis (inflammation of the prostate), bladder neck
contracture (narrowing of the opening from the bladder), urethral tear, rectal wall injury,
and allergic reaction including anaphylaxis (low blood pressure and difficulty breathing)
are possible.
Unlikely but serious heat-related injuries include fistula formation (formation of an
abnormal passage from an internal organ to the body surface or between two internal
organs) and tissue damage to the penis or urethra requiring urostomies (use of a small
section of the bowel to join the ureters from the kidney to the skin of the abdominal wall),
partial amputation of the penis, and/or other therapeutic interventions. Some of these
side effects would require surgery to repair damage to the tissues. None of these serious
side effects have been observed with the use of Prolieve to date.
My doctor has discussed alternative treatments for BPH including watchful waiting, drug
therapy, surgical procedures such as transurethral resection of the prostate, open prostate
surgery, transurethral removal of the BPH growth as well as other heat therapies. My
doctor has determined that the Prolieve Thermodilatation System is the treatment best
suited to address my particular condition. My doctor has answered all of my questions
related to BPH and the Prolieve System and I agree to proceed with the treatment.
Please contact our Cathy Stutts at our Durham office at 919-313-3609 if you have any
further questions.
My signature indicates that I have read and understand this consent form. I will receive a
copy of this consent form for my records.
Signed ____________________________________ Date _____________________
Witness ___________________________________ Date _____________________