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About HIFU Treatment

“HIFU, THE PROSTATE CANCER MALE LUMPECTOMY”: PATIENT KNOWLEDGE AND EMPOWERMENT.

What is HIFU: It is a non-invasive treatment for localized prostate cancer, whereby ultrasound energy is precisely delivered to a focal point within the prostate. The energy originates from the transrectally placed transducer within a specially made probe. Once the energy hits the targeted tissue it is converted to heat or coagulative necrosis, resulting in a precise reproducible thermal lesion. A conglomerate or matrix of such lesions results in thermal ablation of the desired area. In very simple terms, it’s as if one were to shell out the contents of a fruit (prostate gland) while leaving the shell (prostate capsule) intact. One of the unique principles of HIFU is the ability to treat deep within the body without affecting the interfacing tissue. The procedure is not yet approved in the United States, but it is in FDA phase III clinical trials, and is considered an FDA investigational device. HIFU has been approved in many countries across the globe, and in some places considered the treatment of choice for localized prostate cancer. The following is a synopsis of prostate cancer, knowledge and empowerment to help patients make the best/optimal decision on how they treat their prostate cancer.

HIFU is available to Americans patients in countries where it is approved (visit:www.hifumedicalexpert.com), and should be considered a treatment option for any man diagnosed with localized prostate cancer. Particularly men with low risk for recurrence and those concerned about preserving quality of live issues, such as erectile function and/or urinary continence. Additionally, HIFU is an outpatient procedure that typically has no patient down time whereby they can return to normal activities the following day. No matter what your doctor recommends, ultimately the choice of how to treat your prostate cancer, or any other health problems is up to the individual patient. HIFU may be considered a relatively new treatment, as it has only been available for the past 14 years. Most other prostate cancer therapies have been available for decades (visit:www.auaprostatecancerguidelines.com) but there remains huge controversy as to the optimal treatment, and none of them have ever undergone the rigors of an FDA trial, nor have they been FDA approved. They have all been “FDA Grandfathered approved” before FDA medical device regulatory implementations. It is truly unique and amazing that men diagnosed with prostate cancer are willing to undergo “watchful waiting” or “active surveillance,” at the risk of progression of cancer, metastasis and death, rather than choose any of the standard treatment options because of the risk that treatment may result in a worse clinical outcome than the cancer itself. I know of no other cancer where men or women would risk such potential demise and forgo therapy.

Some prostate cancer patients will do a deep and due diligence of research on known treatments around the world and will discover the benefits and high success rates of HIFU. If a patient feels that HIFU may be an alternative treatment option, he needs to ask his doctor about it. If a patient needs to seek an independent HIFU Specialist, there are some listed throughout the United States: particularly on the Internet. Although this service provides access to HIFU specialist, it fails to stipulate the doctor’s experience and/or credentials. An International HIFU Society credentialed physician (visit: www.internationalhifusociety.com for HIFU qualified/credentialed physician referral) is a HIFU physician that has undergone the rigors of training, certification and experience that qualifies him as an expert in HIFU prostate cancer treatment. Ultimately the treatment choice always belongs to the patient. It’s the patient’s choice. Knowledge and education empower the patient so that he can make the most intelligent and sensible decision.

The ideal HIFU patient

The ideal HIFU patient has been diagnosed with localized, low to mid risk of recurrence of prostate cancer. Prostate size is important, and ideally less than 40 grams total size. Most importantly an A-P (anterior-posterior) diameter less than 4 cm. Medical therapy and de-bulking procedures may be performed to assure prostate shrinkage in preparation for HIFU. Typically he is a well-informed patient looking for alternative treat options satisfactory clinical outcome. He is typically of higher social and economic standards, and not willing to accept the standard or “status” treatment. He will challenge his physician on recommended treatment options. Ironically his research may be more likely to make him more knowledgeable than his doctor on the more modern treatment options such as HIFU. He is looking for alternatives that will decrease the risk of complications and compromise of his quality of life issues.

Treatment and Caring for the post HIFU patient

Caring for the post HIFU patient is straightforward and can be managed by most physicians, but preferably one with urologic training. More so, by an HIFU trained urologist. HIFU treatment consists of transrectal whole gland ablation of the prostate gland. This includes the prostatic urethra. The following is a summary of the care of the post-HIFU patient, as well as a synopsis of potential problems or complications with a review of the etiology and management of such complications.

NOTE: In the event of a urologic medical emergency, a board certified urologist (preferably a HIFU trained urologist) should be consulted. If one is not available, the ensuing information may be helpful in diagnosing and managing the problem. However, if you need additional assistance, you may contact Founder and President of the International HIFU Society and USHIFU Founder and Medical Director Emeritus, George M. Suarez, M.D. on cell: 305-310-8238, or office/24 hour answering service: 305-595-0199, or toll free: 1-877-why-leak (1-877-949-5325) Your concerns are a phone call away.

Post HIFU medications should include the following

  • Broad-spectrum antibiotics until Suprapubic or Foley catheter removal and a negative urine culture confirmed. I prefer a Quinolone such as Levaquin or Cipro.
  • Flomax BID (two per day) for 3 months to facilitate bladder emptying.
  • A Non-steroidal anti-inflammatory (NSAID), such as Mobic 15 mg. Q day with meals for 15 days.
  • A PDE-5 inhibitor of choice for 30 – 60 days upon removal of the Foley or S.P. catheter. (Viagra, Cialis, Levitra, Staxyn)
  • Tylenol extra strength as needed. Rarely are additional or stronger analgesics required.

What Happens To The Prostatic Urethra During HIFU Treatment

The urethra runs through the center of the penis from the bladder neck to the meatus; the opening at the end of the penis. The segment that runs through the prostate is known as the prostatic urethra. With standard “whole gland ablation” of the prostate, the prostatic urethra is ablated along with the rest of the gland. Over time the prostatic urethra will grow new epithelial lining, similar to the growth of new skin after a burn. This will re-establish the voiding channel in the form of a normal urethra. The rationale for treating the prostatic urethra is to decrease the risk of leaving potential residual prostate cancer cells, as well as benign (anxiety) PSA producing cells. I like to refer to the concept of whole gland HIFU ablation with preservation of the prostate capsule and the neurovascular bundles (potency sparing HIFU) as, “ The male lumpectomy.” In essence, it is similar to a breast lumpectomy, where the cancerous tissue is removed without injury to the surrounding healthy tissue. This can be safely performed as long as the cancer is confined to the prostate, and there are little to no risks of extracapsular extension.

Is there a role for focal or partial ablation?

Prostate cancer has traditionally been described as multifocal. Which means that if it is present in one area of the gland, there is a good likelihood that it will also be present in other regions of the prostate? More recently there has been a movement toward “tissue sparring surgery” in prostate cancer, as well as treatment for other malignant (lungs, breast, kidney etc.) conditions. The concept of focal prostate cancer therapy was first described focal cryoablation, as it seemed the only way to preserve injury beyond the gland from the lethal deep-freezing temperatures: particularly in the area of the neurovascular bundles. This technique requires a large number of saturation biopsies in an effort to map the areas of cancer. Although promising and gaining popularity, focal/partial ablation remains controversial among some urologists, and there are limited studies and/or long term data on the efficacy of focal or partial ablation. The rationale for tissue sparring HFU focal/partial ablation is an attractive one in that there is less catheter time and/or risk of potential complications.

What Are the Risks of Focal or Partial HIFU?

One of the potential risk of focal HIFU is that potential of residual untreated tissue that may harvest cancerous cells. particularly when image guided saturation biopsies are not performed properly. thereby, focal/partial HIFU, if not properly staged, has a higher risk of reoccurence as opposed to whole gland ablation which can be performed with preservation of potency and urinary control.

Another concern of focal HIFU is the post treatment PSA results are more challenging to follow, as residual prostate tissue, albeit benign cells, will continue to produce PSA. however, with precise MRI image guided/ultrasound fused biopsy technique, the risk of residual or recurrent cancer is minimized.

Unlike other ablative therapies, the physics of HIFU creates unique symmetrical lesions that do not scatter into surrounding tissue. Therefore, one can achieve full whole gland ablation, or total male lumpectomy, without the need/risk to leave residual untreated tissue. This will minimize the risk of residual cancer cells, as well as benign cells with risk of malignant transformation and/or benign PSA producing tissue.

Can HIFU be repeated additional times?

In the event that HIFU is not effective or there is a recurrence, it can be repeated. In fact, HIFU is the only prostate cancer treatment that can be repeated as many times as necessary. Equally unique is the fact that having received HIFU does not preclude the patient to consider any of the original treatment options, i.e.: surgery, radiation, cryosurgery etc. In a humorous comment, one can say: “HIFU burns tissue, but does not burn bridges.” NOTE: The incidence of urethral strictures is much higher in patients that have undergone any type of prior prostate cancer treatment. Thereby, a cystoscopy is recommended in such patients prior to HIFU

Salvage HIFU can be used in treating other forms of prostate cancer recurrences or failures: These include:

  • Prior external beam radiation (EBRT).
  • Prior radioactive seeds.
  • A combination of both radioactive seeds AND EBRT.
  • Prior cryosurgery.
  • Prior radical prostatectomy.

Among the many unique properties of HIFU is the ability to treat prior treatment failures. These include Radiation with/without combined Brachytherapy (radioactive seeds), Brachytherapy in of itself, cryosurgery, as well as post radical prostatectomy. These are more challenging cases, and should be performed only by a highly experience HIFU surgeon. As there is a higher risk of potential complications. The key to these patient selections is based on the integrity and thickness of the rectal wall, as well as the ability to identify a visible image of the tissue: particularly in the post radical prostatectomy patient. Where the most likely location of recurrence is at the apex. Among the many cautions in treating this cohort of patients is proper selection of power settings in order to protect the rectum.

HIFU FAILURE: Can HIFU result on an ineffective treatment, and what may be the reasons? How can they be prevented?

The efficacy of any type of cancer treatment does not depend on any single element, but on multiple parameters. It has been demonstrated that even in cases where the entire prostate was successfully surgically removed to include negative margins, and where the key factors of PSA and Gleason score are favorable for low risk for recurrence, there can still be cancer relapse. I am of the opinion these types of cancers have a biologic behavior independent of treatment. Possibly associated with personal attributes such as: genetics, immune system, diet/nutrition, and exercise may influence clinical outcomes.

However, like other forms of prostate cancer therapy, there are fundamentals of HIFU that are crucial for obtaining optimal outcomes. Perhaps the most important is surgeon’s experience and volume of cases performed. It has been vastly reported that high volume surgeons, regardless of specialty, will have superior clinical outcomes. In the United States the average university urology residency training facility will perform approximately 150 prostate cancer procedures during the four-year training period of a resident. Upon finishing their training, the typical urologist will perform between three to ten prostate cancer procedures per year; hardly a large volume to assure during residency training or clinical practice to make for a highly trained proficient prostate urologic surgeon. This is particularly true in certain procedures such as Robotic prostatectomy that require a longer training curve or additional fellowship training in order to achieve proficiency. Although HIFU training and learning curve is much simpler than many other treatments, high volume HIFU surgeons definitely have an advantage and demonstrably superior clinical outcomes. When I first started performing HIFU in 2003, there was no other American urologist (except FDA clinical trials at Indiana University) in North or South America using the technology. It was in the same year that I founded the International HIFU Society, a 501(c) 3 not profit foundation, to establish uniformity in training urologist on HIFU on a global stage. Yet, it was not until 2005 that American and Canadian urologist initiated an interest in HIFU and began travelling to my Global training courses. In the ensuing years, I have had the opportunity to see the evolution and improvement of the technology, particularly the software. In short, unless a doctor is a regular HIFU user, he may be learning new software applications continuously and playing catch up forever. Since 2003 there have been additional proctor training and Physician Instructional Manuals (PIM) to facilitate training new doctors. But nothing makes up for the experience over time and high volume of procedures.

There are a number of reasons why HIFU may not be effective, as well as relative contraindications. The most absolute contraindications are: 1) inability to dilute the rectal sphincter to accommodate two finger (index and middle finger) dilation, 2) large amounts or cluster of calcification’s, particularly if they are greater than 1 cm. in width and/or solidly hyperehoic with demonstrable post calcification shadowing. In such cases a pre HIFU TURP or GreenLight laser should be considered, 3) large cluster of radioactive seeds, particularly if close to the rectal wall. Again, TURP or GreenLight may be considered in an effort to dislodge them. When considering a pre HIFU TURP or GreenLight laser, special consideration is recommended to stay away from the external sphincter in radiated or cryosurgery patients to prevent the risk of urinary incontinence. The presence of large calcification’s or radioactive seeds may cause suboptimal delivery of energy to the area. Resulting in insufficient energy to provide satisfactory tissue ablation and coagulative necrosis. Similarly, this may result in deflection or scatter of energy and potential injury to surrounding healthy tissue. The later may affect the rectum, urinary sphincter, neurovascular bundle or pubic bone.

The other reasons HIFU may not have an effective outcome are operator dependent issues. HIFU is a hands on, all eyes on, at all times interactive procedure. It is cannot run on autopilot or on GPS guidance. The continuous changes of the prostate and tissue response, as well as necessary adjustments of energy and rectal wall distance require the surgeon be engagement throughout the entire procedure. There are numerous built-in safety alarms in the Sonablate– 500 technology, but operator engagement and interaction is mandatory. This is one of the reasons that any single HIFU surgeon should not perform more than two to three cases per day in order to avoid fatigue and/or distractions.

HIFU: Potential Post HIFU complications: Every treatment options bears the face of options, alternatives, risks and potential complications

Post HIFU complications are not much different from those seen with other treatments for prostate cancer or other urologic procedures. The etiology and management of such potential complications are not any different from if they occurred on their own, independent of HIFU. They are listed below under 1) Complication, 2) Etiology 3) Management. These are separated into early complications that are more likely to occur in the first 3-6 months after HIFU, and late complications that are more likely to occur after 6 months from treatment.

POTENTIAL EARLY COMPLICATIONS

Management of the Suprapubic (S.P.) Catheter: The S.P. catheter will serve as the drainage apparatus until spontaneous voiding is resumed. After day five post HIFU the S.P. catheter should be closed off and self-voiding trial initiated. The patient should attempt voiding on his own. The S.P. tube should be opened after each voiding attempt. The patient should maintain a voiding diary documenting voided volume and post voided residual. Once the patient is voiding > 80 percent of the residual volume for 2-3 consecutive days, one can consider S.P. removal. Wound care of the S.P. tube consists of daily cleansing with soup and water and hydrogen peroxide, followed by Triple antibiotic ointment or Neosporin twice per day. Gauze with paper tape is recommended for wound coverage.

Upon removal of the S.P. catheter, the puncture site should close spontaneously within 24-48 hours. Lack of spontaneous closure may be indicative of a bladder outlet obstruction. In which case a cystoscopy should be performed to ascertain any such problems. Placement of a temporary Foley Catheter (48-72 hours) may assist in faster closure of the site. But is typically not recommended.

Urinary Retention: Immediately post HIFU:

Etiology: Urinary retention is normal in the immediate post HIFU period lasting anywhere from 7-21 days to several weeks. This is a result of edema and swelling secondary to the thermal effect from the HIFU treatment on the prostate. After HIFU, most patients will have a Percutaneous Suprapubic catheter (SP tube) with a valve that remains opened to gravity drainage in the first few days after the procedure. The catheter is closed off to drainage when the patient is to begin their voiding trial. This typically is initiated at day five after the treatment. The S.P. tube is secured within the bladder by a fluid filled balloon, as well as sutured to the skin. NOTE: There and several types of S.P. catheters. Occasionally a patient may have a standard Foley catheter instead of the SP tube. (See contraindications for S.P. catheter below)

Management: If the S.P. stops draining, check the tubing for visible kinks or blood clots and/or tissue debris. Vigorous irrigation with a catheter tip syringe may be required. If obstruction is not resolved with flushing, consider that the S.P. may have become dislodged.

Inadvertent dislodgement of Foley catheter/ Suprapubic Tube:

Etiology: Inadvertent dislodgement of the drainage catheter will most likely result in urinary retention that will require the placement of either a Foley Catheter or a new SP Tube.

Management: Catheterization in this early post HIFU period may be difficult due to edema and/or swelling. The use of a well lubricated Coude’ Tip Catheter will facilitate easier placement. In the event a urethral catheter may not be placed with ease, it is better to abandon any further attempts at transurethral placement that may cause additional urethral trauma, stricture/scar formation, or risk rectal injury. Direct visualization with flexible cystoscopy and the placement of a catheter over a guide wire is recommended as opposed to “blind instrumentation.” Urethral sounds or a catheter guide wire is absolutely contraindicated. CAUTION: The recently treated prostate with HIFU is friable and susceptible to rectal injury and potentially result in a prostatic-rectal fistula.

In order to prevent inadvertent dislodgement of Foley catheter/Suprapubic Tube, the catheter should be additionally secured to the body with either a catheter strap or silk tape. The patient should be advised to “hand hold secure” the catheter when ambulating or with any abrupt movement such as getting in and out of bed or from a sitting to standing position.

Urinary Retention after the drainage catheter has been removed:

Etiology: Urinary retention may occur at any time after the drainage catheter is been removed. The causes may be: 1) Sloughing of necrotic tissue, debris or a mucus/tissue plug. 2) Scar tissue from a urethral stricture or bladder neck contraction.

Management: In the event the tissue is not expelled, a temporary Foley catheter may be placed for 48-72 hours. This will relieve the retention, as well dislodge the tissue. Typically the patient will easily void thereafter. Cystoscopic findings in the first 3-6 months after HIFU will reveal variable debris like appearance of the ablated necrotic tissue or tissue plug. Conservative management with temporary Foley catheter placement is the recommended treatment as opposed to tissue resection (TURP), which carries a potential risk of injury to the sphincter and subsequent urinary incontinence.

The phenomenon of “tissue plug” may occur on more than one occasion during the post HIFU period, as the ablated tissue, or necrotic material, may take several months to eliminate. A mucus/tissue plug may pass on its own. In which case the patient is encouraged to drink lots of water, and take a 20-30 minutes warm sitz bath once or twice daily. It is only after more than three or more such conservative attempts that a transurethral intervention should be considered. CAUTION: During this early period after HIFU, the anatomic landmarks of the prostate may be difficult to identify, i.e.: bladder neck and veru montanum: making it riskier to cause inadvertent injury to these structures. In the event intervention is required, using the cold TURP loop one can dislodge the tissue into the bladder and irrigate it out with a catheter tip syringe.

Urethral Stricture Disease (USD):

Etiology: Urethral strictures may occur from the simple passage of a Foley catheter and/or any urethral instrumentation, and to a certain degree is common to all therapeutic modalities in the treatment of prostate cancer. Generally, urethral strictures occur as the result of injury or trauma to the urethral mucosa. In the HIFU patient, this can arise secondary to catherization and/or to infection/inflammatory process. However, it is more likely to occur as a result of HIFU energy delivered outside the prostate in the peri-prostatic tissue. The post HIFU strictures are most common at the apex. Where the tissue has a smaller diameter, and where any energy outside the prostate will result in thermal injury and devascularization of peri-prostatic fat. This is particularly true when HIFU energy is inadvertently delivered anterior and/or above the apex. This will result in necrotic avascular-scarred tissue of prostate and peri-prostatic (fatty) tissue.

The other etiology of USD may be from misdirected energy into the most distal part of the apex: either directly or inadvertently by scatter from calcifications, pre-focal heating or Brachytherapy seeds. Technical adjustment using the stacking/update software may prevent this from happening. One important precautionary measure is to pause, stack and update at twenty-five to thirty percent into the initial treatment of each zone. The significance of this is that often times the gland will swell or move toward the base. Thereby, resulting in HIFU lesions have frontage above and anterior to the apex. The response of fatty tissue is different from prostate tissue. As different types of tissue will have a difference in response due to characteristic and coefficient of absorption unique to the tissue. The union of devascularized prostate and fat leads to an extrinsic scarring onto the apex, peri-prostatic tissue and urethra itself. Similarly, to a bone in steak or bacon: the meat and the fat simply do not cook alike.

Management: The standard treatment of strictures is:

  1. Urethral dilation, ideally soft dilation, with sounds reserved as a last measure
  2. Internal Optic Urethrotomy,
  3. Primary Urethral-urethrostomy is rarely necessary.

Most commonly, strictures can be managed by initial soft dilation, with possibly needing subsequent or intermittent self-catheterization (ISC) for a short period. An internal optic urethrotomy with a cold knife or Holmium laser with/without subsequent dilation may be necessary if conservative management fails. The use of Intermittent self catheterization (ISC) is preferred as opposed to prolonged indwelling catheter in preventing UTI’s, urethritis and risk of aggravating further stricture formation. When an indwelling catheter is required, typically 2-3 days are sufficient. Urine culture and antibiotics suppression is recommended.

Bladder Neck Contraction:

Bladder neck contraction (BNC) post HIFU may result from misdirected energy into the bladder neck; either directly or inadvertently by scatter from calcifications, pre-focal heating or Brachytherapy seeds. By maintaining the bladder full during the procedure, misdirected HIFU energy or lesion should be defused by the “heat sink” effect of the fluid filled bladder and should prevent BNC. To prevent bladder over distention, 50-100 cc’s of fluid should be drained from the SP tube between treatment zones.

Management: The initial management of the post HIFU BNC should be soft catheter dilation. If these conservative measures are unsuccessful, a standard bladder neck incision can be made at five and seven O’clock, and should release the BNC.This can be performed with either a cold knife urethrotomy, TURP of BNC or Holmium laser.

Urinary Tract Infection:

Etiology: A urinary tract infection (UTI) may occur upon the simple placement of the indwelling catheter and/or Suprapubic tube. Acquired UTI may also occur because of the prolonged indwelling catheter. Suppressive antibiotics may cause the growth of resistance bacteria and/or colonization, making for another clinical challenge. Immediately after HIFU, patients are maintained on suppressive antibiotic therapy. Ideally, a urine culture should be obtained 48-72 hours prior to removing the catheter/Suprapubic tube. The catheter/SP tube should never be removed unless there is no infection as confirmed by a negative culture. If sensitivity of a positive culture mandates a different antibiotic, the voiding efforts should be discontinued with drainage catheter placed again to gravity drainage, and not removed until the infection is resolved.

Management: An infection that occurs after the drainage catheter has been removed should be treated in the same fashion as all urinary infections as per culture and sensitivity. CAUTION: A post void residual should be performed to determined/rule out urinary retention that may promote the infection or resist antibiotic therapy. As high residual urine provide an excellent growth media for bacteria.

Epididymitis/Orchitis:

Etiology: The etiology of epididymal-orchitis is an underlying urinary tract infection that has spread to the testicles.

Management: Epididymal-orchitis should be treated with standard broad-spectrum antibiotics until definitive culture and sensitivity are available. Additional use of non-steroidal anti-inflammatory therapy may be helpful.

Gross Hematuria, Immediate versus Delayed:

Etiology: Post HIFU gross hematuria with potential clot retention may occur in the immediate post HIFU treatment as a result of inadvertent piercing a prominent vascular structure during the placement of the S.P. catheter.

Management: This may resolve with catheter irrigation and by adding water to the S.P. balloon while placing it on slight to moderate traction. Placement of a Foley catheter and establishing three-way continuous bladder irrigation may assist in resolving the problem. Cystoscopic-guided cauterization of a bleeder at the S.P tube entrance site may be necessary if conservative traction does not resolve the bleeding. Cystoscopic findings typically reveal a small venous bleeder adjacent to the S.P. puncture site.

Delayed hematuria may occur at anytime in the ensuing months after HIFU. The etiology may be from dislodgement of necrotic tissue, an isolated prostatic bed bleeder and/or hemorrhagic prostatitis. Increased fluid intake (8-10 glasses of water/day), discontinuing of any anticoagulants may resolve the problem. Otherwise, an indwelling three-way catheter may be placed in anticipation that continuous bladder irrigation will be necessary. If unresolved, cystoscopy with evacuation of clots and possible cauterization may be required. Hemorrhagic prostatitis may respond to double doses of Avodart (One or two BID)

Preventing the above Co-morbidities:

An alternative to dealing with the potential co-morbidities of necrotic debris, mucous plugs, gross hematuria, urinary tract infections and prolonged catheter time, as well as lower tract obstructive (bother/irritive) symptoms is to consider a pre-HIFU debulking procedure, such as a XPS GreenLight laser, as a preferred treatment of choice in an outpatient setting or a TURP. This will decrease the risk of all of the above co-morbidities. Additionally, by creating an empty intra-prostatic cavity will result in the normal intra-operative HIFU tissue swelling that takes place inward toward the cavity, and not outward (HIFU swelling). This will decrease the risk of normal swelling/expansion of tissue toward the base, A.P and/or lateral borders. A well-performed debulking procedure, particularly with the new XPSGreenLight laser, will also decrease HIFU operative time by allowing compression of the gland.

Rectal Injury:

The incidence of rectal injury after HIFU with the SB-500 is less than 0.3 %.

Etiology: The etiology of rectal injury may occur secondary to inadvertent energy/thermal injury into the rectum. This can occur as a direct result of High-energy on the rectum or on Denonviller’s fascia. The most susceptible areas of injury to the rectum are the two lateral borders and the apex of the prostate where the anatomy “tents” or curves. The probe can be re-positioned using the stepper to accommodate these anatomic landmarks. Rectal injury may also occur secondary to the scatter of energy bouncing off calcifications, pre-focal heating or in the presence previously placed radioactive seeds. Another form of thermal rectal injury may also occur from the accumulation of heat close to the rectal wall via a secondary medium such as feces, excess gel or lubrication. These may act as a conduit for heat accumulation.

Management: Minor rectal mucosal burns or irritation may be managed by local therapy consisting of warm sitz bath and local proctofoam-type application and high fiber/residue diet. It is not much different from local treatment of hemorrhoids or a minor rectal fissure. Although rare there is a risk of a prostatic-rectal fistula. A small fistula may be managed conservatively with urinary (catheter and/or SP tube Diversion) for 4 – 6 weeks, suppressive antibiotics, anticholinergics and a high residue fiber diet. A larger, or non-healing fistula may require a temporary colostomy and urinary diversion with eventual repair with a potential need for an anal rectal flap. However, the incidence of fistula with the Sonablate – 500 is rare and reported at < 0.3 percent. I am not aware of any fistula associated with the SB-500 that has required anything other than conservative management. In contrast, a much higher incidence of fistulas have been reported with the Ablatherm (EDAP) HIFU technology, as well as the need for surgical intervention. This is more likely due to the larger (both height and width) Ablatherm HIFU lesion. Thereby, creating a larger defect and greater likelihood for a need for more aggressive management and/or surgical intervention. Any type of blind transrectal procedure is contraindicated until after three months post HIFU. No instrumentation should be done unless under direct vision. Blind instrumentation is a high risk to a fistula or rectal injury.

POTENTIAL DELAYED POST HIFU COMPLICATIONS

The potential late complications after HIFU are similar to other treatment modalities for prostate cancer, but according to peer review medical journals occur with less frequency with HIFU.

Erectile Dysfunction:

Etiology: The etiology of erectile dysfunction in the post HIFU is similar to other therapies for localized prostate cancer: inadvertent injury to the neurovascular bundle (NVB). The injury may be as a result of direct HIFU energy on the NVB, or from secondary scatter of energy such as pre-focal heating or energy bouncing off calcifications or Brachytherapy seeds. HIFU with the Sonablate – 500 has the ability to utilize an embedded Doppler that will assist in identifying the NVB. Nonetheless, the risk of injury to the NVB is always possible.

Penile rehabilitation: as a proactive measure to decrease the risk of erectile dysfunction has demonstrated to decrease the incidence of potency, as well as decrease the incidence of penile atrophy or shortening. Which I have never seen with HIFU, but have with just about every other treatment modalities. Penile rehabilitation in the post prostate cancer treated patient consists of starting the patient on one of the PDE-5 Inhibitors (Cialis, Viagra, Levitra or Staxyn) upon removal of the catheter. Ideally, the simultaneous use of a Vacuum Constriction Device (VCD) is recommended. Restoration of blood flow is essential in “penile rehabilitation”. In the event erectile function is not returned to baseline function at 3 months post HIFU, the patient may be considered for additional medical therapy with intraurethral Muse or direct penile injection of Caverject/Tri- mix. A one-year conservative management is recommended before initiating a surgical intervention (inflatable penile implant), as most patients will return to baseline function three to 12 month – one-year mark from treatment date.

Urinary incontinence:

Etiology: The etiology of urinary incontinence in the post HIFU patient is similar to other therapies for localized prostate cancer and results from injury to the external urinary sphincter. According to peer review medical journals reports, urinary incontinence is the least often of quality of life complications associated with HIFU.

Management: The first step in evaluating urinary incontinence in the post HIFU patient is to rule out the possibility of “over flow” incontinence secondary to urinary retention. The best way to determine this is by the use of a post-void ultrasound of the bladder (bladder scan), and rule out bladder outlet obstruction by direct visual cystoscopy. The possibility of an infection must also be ruled out, as it can cause irritive symptoms, urgency and urge incontinence.

The initial treatment for urinary incontinence should be initiated with Kegel exercises along with medical therapy with one of the many drugs available for the treatment of overactive bladder or incontinence. A minimum of 1 year of conservative management is recommended before initiating a corrective surgical alternative, as most patients will regain urinary control.

Osteitis Pubica (Pubis): Osteitis Pubica is defined as an inflammatory process of the pubic bone it is rarely associated with HIFU, and is completely preventable.

Etiology: It occurs when direct or inadvertent energy is delivered to the pubic bone. Likewise, it can occur secondary to misdirected energy “bouncing-off” calcifications, radioactive seeds or pre-focal heating. This can be prevented by continuously observing the delivery of HIFU energy, stacking, and update stacking with editing the new images as necessary. The space between the anterior capsule of the gland is minimal, (particularly in the thin patient) and consists of peri-prostatic tissue and the Dorsal Vein Complex. HIFU Treatment should never extend above and/or anterior to the anatomic capsule. Acute and severe pelvic pain is the most common clinical presentation of Osteitis Pubica. Without immediate treatment and progression, it may progress to destabilization of the pelvic anatomy, difficulties ambulating and potentially a permanent gaited walk. Diagnosis is based on the clinical history and imaging studies of a KUB, CT scan or MRI. A review of the actual HIFU case from the hard drive will document if the treatment extended into the bony structure of the pelvic bone.

Management: The clinical management of minor cases is based on physical therapy, Non- Steroidal anti-inflammatory, and possibly direct injection of the site with steroid. In more severe cases, or if conservative therapy is unsuccessful, debridement of the affected tissue, with bone graft and or orthopedic stabilization with hardware may be required.

Post HIFU elevated PSA Nadir: PSA has clearly been demonstrated to be prostate specific and not prostate cancer specific. Thereby, the post HIFU PSA nadir at three months is considered a surrogate value to treatment outcome. The ideal post HIFU PSA nadir should be less than 0.5 and preferably < 0.2. However, even with total whole-gland ablation of the prostate, there may remain residual in-situ prostate tissue that is capable of producing benign PSA levels. A nadir at three months post HIFU of greater than 0.5 ngm and/or three progressive nadir elevations 3 months apart should be considered as a potential residual or recurrent cancer and mandate a prostate biopsy. A PSA is recommended every three to four months post HIFU for a minimum of five years. Subsequent PSA determinations may be extended to every six months, but remains at the physician discretion. Three progressive PSA elevations is an indication for a prostate biopsy.

Contraindications for S.P. catheter (suprapubic catheter)

In certain situations there may be contraindications to the placement of a S.P catheter. These include a history of extensive pelvic surgery, a history of bladder cancer, obesity that precludes identification of important anatomic landmarks for safe placement of S.P. catheter. IN such cases, one can treat the anterior and middle section without a catheter. It is recommended that a Coude Foley catheter be place before initiating the treatment of the posterior zone. This will allow introduction of the catheter with greater ease.

NOTE: The above guidelines are the opinions/suggestions of The International HIFU Society (www.internationalhifusociety.com), a 501(c) 3, a not for profit organization, (established in 2001, accepted by the IRS 2004) and do not represent the views and/or opinions of any other entity. The recommendations for treatment are, and should be tailored to the individual patient and remain at the discretion of the treating physician.

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