VESICO-RECTAL FISTULA ASSOCIATED WITH HIFU

Vesico-rectal fistula associated with HIFU

Clinical Presentation
Vesico-rectal fistula are extremely rare with HIFU with a less than .5% repoeterted incidence.The presenting symptoms and signs of enterovesical fistulae occur primarily in the urinary tract. Symptoms include suprapubic pain, irritative voiding symptoms, and symptoms associated with chronic urinary tract infection (UTI). The hallmark of enterovesical fistulae may be described as “Gouverneur syndrome”, namely, suprapubic pain, frequency, dysuria, and tenesmus. Other signs include abnormal urinalysis findings, malodorous urine, pneumaturia, debris in the urine, hematuria, and UTIs.

The severity of the presentation also varies. Chronic UTI symptoms are common, and patients with enterovesical fistula frequently report numerous courses of antibiotics prior to referral to a urologist for evaluation. Urosepsis may be present and can be exacerbated in the setting of obstruction. It has been demonstrated in dog models that surgically created colovesical fistulae are tolerated well in the absence of obstruction.
Pneumaturia and fecaluria may be intermittent and must be carefully sought in the history. Pneumaturia occurs in approximately 50%-60% of patients with enterovesical fistula but alone is nondiagnostic, as it can be caused by gas-producing organisms (eg, Clostridium species, yeast) in the bladder, particularly in patients with diabetes mellitus (ie, fermentation of diabetic urine) or in those undergoing urinary tract instrumentation. Pneumaturia is more likely to occur in patients with diverticulitis or Crohn disease than in those with cancer. Fecaluria is pathognomonic of a fistula and occurs in approximately 40% of cases. Patients may describe passing vegetable matter in the urine. The flow through the fistula predominantly occurs from the bowel to the bladder. Patients very rarely pass urine from the rectum.
Symptoms of the underlying disease causing the fistula may be present. Abdominal pain is more common in patients with Crohn disease, but an abdominal mass is discovered in fewer than 30% of patients. In patients with Crohn disease who have a fistula, abdominal mass and abscess are more common.




General evaluation of vesico rectal fistula

Iatrogenic pathophysiology
Iatrogenic fistulae are usually induced by surgical procedures, primary or adjunctive radiotherapy, cryosurgery, HIFU and/or post procedural infection. Surgical procedures, including prostatectomies, particularly the post radiated salvage radical prostatectomy patient, as well in resections of benign or malignant rectal lesions, and laparoscopic inguinal hernia repair have been associated with fistula formation. Unrecognized rectal injury at the time of radical prostatectomy is an uncommon but well-documented etiology of recto urethral fistula.

Scatter or emission of treatment from external beam radiation, brachytherapy, HIFU or cryotherapy to bowel in the treatment field can eventually lead to fistula development. Radiation-associated fistulae usually develop years after radiation therapy for a gynecologic or urologic malignancy. The post HIFU fistula is more likely to develop in association with blind instrumentation or spontaneously at two to three months after the procedure. In the first three months after HIFU, there is recognized sloughing of the entire prostatic urethra. This is as a result of coagulative necrosis secondary to HIFU. During this period of time the prostatic tissue is ulcerated and friable. Making it extremely sensitive to blind instrumentation and at greater risk of injury to penetrating the surrounding tissue, and more so the rectum.



Fistulae develop spontaneously after perforation of the irradiated intestine, with the development of an abscess in the pelvis that subsequently drains into the adjacent bladder. Radiation-associated fistulae are usually complex and often involve more than one organ (eg, colon to bladder). Although rare, fistulae due to cytotoxic therapy have been reported in a patient undergoing a CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) regimen for non-Hodgkin lymphoma. Therefore, past medical history of such medications should be considered.



The incidence of radiation-induced fistula associated with urologic and gynecological (recto vaginal or vesicovaginal) cancers is approximately 0.5% to 1%. The overall risk of a fistula formation is the same as the risk of rectal injury following a radical prostatectomy or various forms of EBRT, and interstitial prostate brachytherapy. The patients at highest risk of a fistula associated with HIFU are those undergoing a salvage procedure.




Traumatic pathophysiology
Urethral disruption caused by blunt trauma or a penetrating injury can result in fistulae, but these fistulae are typically rectourethral in nature. That is why any need for instrumentation in the post HIFU patient should be done under direct vision. In the post surgical, or HIFU patient, the history of prior surgery alone should be sufficient to properly diagnose the etiology of the fistula. However, one should always keep in mind the possibility of associated pathology such as bowel malignancy, inflammatory bowel disease and bladder cancer as a contributing factor. Particularly if the fistula fails to heal spontaneously after attempts at conservative management have been exhausted.









DIAGNOSTIC TESTING


· Charcoal test: Oral activated charcoal can confirm the diagnosis of enterovesical fistula.

Several hours after ingestion, flecks of charcoal can be noted in the urine.

· Cystoscopy and possible biopsy.

· Endoscopic visualization has the highest yield for the identification of enterovesical fistula.

•Eighty to 100 percent of cases demonstrate bullous edema, erythema, or exudation of feculent material from the fistula site
•Generally, colonic fistulas occur on the left side and dome of the bladder, whereas small bowel fistulas occur on the dome and right side of the bladder.
•Biopsy of the fistula is indicated in cases where malignancy is suspected. · Colonscopy and barium enema.



· Although less common than diverticular disease, it is important to exclude primary intestinal malignancy as the cause for the fistula.

· CT or MRI of the pelvis.

· Air in the bladder in the absence of prior lower urinary instrumentation is highly suggestive of an enterovesical fistula.

VCUG

· May demonstrate the fistulous connection.

· In some cases, however, the fistula can act as a "flap valve" and contrast will not be seen entering the bowel.





HIFU FISTULA: INTRA AND PERI-OPERATIVE PREVENTION



· Standard DRE, followed by slow and careful insertion of a second finger. I do not use forceful dilation, but simple leave the two fingers in place until the rectum and sphincter accommodate to both fingers...and it does relax and accommodate with time. This cannot be forced or hurried.

· Abort the procedure if unable to accommodate the index and middle finger in the rectal vault or if excessive bleeding.

· Keep the index finger pushing down at the 6 o'clock position during gentle and slow introduction of the probe.

· I prefer using the latex allergy condom. They are more durable and less likely to break. Therefore, less risk of having to reinsert the probe again. Multiple reinsertions only add to potential trauma to the rectum.

· I prefer two (double) “O rings” at the proximal end of the condom. This will reduce the potential of breaking the condom seal and the risk of getting air in the condom---another risk of having to remove and reinsert the probe again.

· I prefer bring the temperature of the Sonochill down to as low as possible in order to decrease heating.

· I prefer to use the minimum needed amount of water in the condom. This decreases the amount of pressure on the gland during treatment. My theory on this is that the less volume of interface between the transducer and the gland, the greater the coefficient of absorption of energy capability in the tissue. This, versus a greater volume of interface, may result in greater compression of the gland and less absorption of energy in the compressed gland. This can potentiate scatter of energy in the wrong direction, such as the rectal wall., NVB, sphincter.

· The rectal wall must have a minimum of 4-5 mm. in thickness without compression and a similar thickness should be maintained at all times. Undue compression of the rectal wall increases the risk of rectal wall injury. This is tissue that previously been treated and is more likely to be fibrotic and less vascular. Thereby compromising the ability of healing.

· The recurrent treatment glands are typically small and can be treated in two zones. All treatment zones (4 and 3 cm. probes) should be performed with the "extra" icon on (3 on, 6 off cycle)

· If the gland is very small with a short AP distance, try to get most of the overlap in the anterior zone. Even if it means extending the treatment outside the capsule. The distance from the anatomic capsule to the "surgical capsule" when doing a RRP is the thickness of the vascular pedicle and peri-prostatic fatty tissue. It is several mm. in thickness, and unlikely hurt anything by slightly treating lateral in this region.

· I am a firm believer in maintaining RWD at the same level in the reference and real time images as much as possible. I prefer to add water when the distance in the real time images changes beyond one-tenth of a mm. For example, if the real time image drops from 1.5 cm to > 1.4, I will pause and add small amounts of water to return to the reference image distance of 1.5 cm. I believe these changes occur due to build up of steam and swelling within the gland. This however, is more common in the primary therapy tan recurrent cases. The pause time will also allow more cooling time.

· I also believe in pausing and stacking at 1/3 interval into each zone. This will assure that there has not been movement of the gland toward the base. This allows the operator to remove HIFU lesions that are now anterior and above the apex- the site of the most common strictures. It also allows adding or subtracting any necessary lesions at the level of the base. Which is where the gland retracts. Stopping and stacking at 1/3 interval will also add cooling tome to the procedure.





THE MOST COMMON CAUSES AND SITE FOR A FISTULA

FORMATION ASSOCIATED WITH HIFU


· The most common cause of a fistula in the HIFU patient occurs when treatment results in misdirected energy into the rectal wall and/or below Denonvillier's fascia.

· Misdirected energy can occur from pre-focal heating, or from energy bouncing off calcifications or radioactive seeds. Continuous observation during treatment and adjustments of rectal wall distance and energy are the best method of preventing this from happening.

· The recommended energy adjustment to rectal wall distance should be continuously monitored. Particularly at the first lesions at Apex wish marks the beginning of each treatment row. This is where there can be the most variation in rectal wall distance as the sequence of lesions alternates from side to side (M versus P). This is easily accomplished by moving the "mouse" over the energy icon to the right of the watt adjustment slide bar. The adjustment can be performed moving the energy marker, or by clicking on the F12 icon and using the up or down arrow.

· Treatment into the rectal wall or below Denonvilliar’s fascia most commonly occurs during treatment of the posterior zone. But can occur in any zone, and at anytime. It is most likely to occur at the most lateral borders of the prostate where the crescent shape of the gland is most evident as the gland "tents downward." Likewise toward the apex, where it begins to take an upward orientation or slopes up as it gets closer to the external sphincter.

· Prevention of treatment below Denonvilier's fascia at the lateral borders and toward the upward slope of the prostate can be achieved by adjusting the stepper and/or water in the condom accordingly.

· Be extremely careful to not exceed the 2 cm limit rectal wall distance when treating toward the most lateral sides of the prostate.

· Always allow a 1 - 1.5 mm safety margin between the lower limits of the treatment limits to Denonvillier's fascia. The HIFU lesion is "cigar shaped" at the tip. This will allow some degree of treatment to be extended downward.

· I personally do not feel it is necessary to compromise the energy level or "power down" when treating the posterior zone, and in fact this is the site most likely to have cancer whether primary or recurrent.








POST HIFU PROTOCOL FOR PREVENTION OF RECTAL FISTULA IN RECURRENT TREATMENT CASES




· Withhold voiding trial until 2 weeks post HIFU in recurrent treatment cases.

· Place patients on anticholinergics for the first 10 - 12 days. i.e.: Vesicare 10 mg. Q day.

· Place patient on high residue diet for 2 weeks, or until voiding. This will need to be detailed and provided to patients.

· Add Metamucil as a bulk forming laxative to combat potential constipation. As well as a synergy to high residue diet.

· Urine culture and sensitivity several days before removing S.P. catheter to confirm no infection.

· Hold off removing S.P. if the culture is positive and/or resistant to antibiotic patient is taking.

· Post-void residual determination by ultrasound or bladder scan at 48 hours after S.P. tube is removed.

· Weekly nurse call to patient for the first 3-4 weeks, bi-monthly for the first 3 months, followed by monthly for the next 3 months.

· Absolutely no instrumentation unless under direct vision, and with appropriate antibiotic prophylactic i.e.: Gentamicin or Rocephin I.M.

· Emergency medic alert card with contact numbers to be mandatory carried at all times.

· Patients should be urged to curtail any heavy excessive exercise or work.

· They should also be urged to not travel beyond the U.S. for the first six months.




MANAGEMENT OF POST HIFU FISTULA

· Always be on the lookout for early symptoms of the potential of a fistula in the post HIFU patient. Educate the patient to be alert of any of these symptoms.

· Early symptoms; New and acute onset of peri-rectal pain and/or sense of fullness. A sense constipation or desire to have a bowel movement but can't. Acute onset of watery diarrhea particularly associated with voiding. The presence of gas or fecal material per urethra. Fever, chills and general malaise.



· Immediate management: Place a Foley catheter or Suprapubic catheter. Either one should be done under direct vision. I prefer a Suprapubic catheter using a flexible cystoscope for guidance and confirmation. Obtain a urine culture, baseline CBC and blood culture if febrile. Place the patient on appropriate broad-spectrum antibiotics, anticholinergics and high residue diet. Obtain urine culture and sensitivity weekly. Restrict activities as much as possible to only necessary. If the Suprapubic remains in place for a prolonged period of time, change every three weeks.

· Consult a colo-rectal specialist. It is best to get him on board from the beginning in the event additional intervention such as a temporary diverting colostomy may be required. The post HIFU fistula is typically very small and will heal on it's own with the above measures. Be patient and consciously reassuring to patient and family.

· The post HIFU fistula will typically heal on it's own within 6 to 8 weeks. If clinical resolution of the fistula remain doubtful, a voiding cystourethrogram via the Suprapubic catheter and/or a CT Scan combination may be helpful in confirming closure.






George M. Suarez, M.D.

Co- Founder, Medical Director Emiritus

USHIFU. International HIFU



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