Transurethral Balloon Divulsion Of Prostate
Jose M. Hernandez-Graulau, M.D.
From the Department of Urology, New York Medical College, Valhalla, New York
ABSTRACT -- Benign prostatic hypertrophy (BPH) is the most common cause of urinary outflow obstruction. Transurethral resection of the prostate (TURP) is the preferred treatment for symptomatic BPH and is considered the gold standard of treatment. Balloon dilatation of the prostate (TUBD), besides some criticism, represents a nonoperative treatment alternative for treatment of symptomatic BPH which is simple and safe. We describe the technique of TUBD, balloon technology, as well as advantages and disadvantages of balloon dilatation.
Benign prostate hypertrophy (BPH) is without a doubt the most common cause of urinary outflow obstruction. Over the years, transurethral resection of the prostate (TURP) has become the preferred treatment for symptomatic prostatic obstruction, and is indeed the gold standard of treatment today.
More than 350,000 prostatectomies are performed annually in the United States and the number is rising.(1) It is surprising, therefore, that the symptom status and quality of life after prostatectomy are not well documented.(2) Recently the safety and efficacy of TURP for all patients has been questioned.(3) Investigations to study alternative medical and surgical therapies for BPH are currently on-going.
Until recently, prostatectomy and watchful waiting have been the only two options for men complaining of prostatic symptoms. Today, an array of new alternative treatments have begun to emerge. Among the alternatives to prostatectomy -- gonadotropin inhibitors, (4-5) enzymes, (6) alpha-adrenergic blockers, (7-11) antiandrogens, (12-13) ultrasonic aspiration, (14) hyperthermia/microwave, (15-17) transurethral incision, (18-19) and urethral stents (20-25) -- one must consider balloon dilatation of the prostate, and its merits and limitations.(26-38) It has been suggested recently that balloon dilatation of the prostate is primarily a placebo effect.(39) No one can deny, however, there is a placebo effect in most every therapy, including pharmacotherapy. It is hard to believe that a placebo effect can make a man void who either was in urinary retention, failed pharmacotherapy, or failed a course of prostatic hyperthermia treatment.
History
Prostatism has been known to afflict the male population for centuries. Records of prostatism causing difficulty with micturition date back to Egyptian papyruses from the fifteenth century B.C. discovered in Luxor in 1956. It is not surprising that the concept of prostatic dilatation for the relief of urinary outflow obstruction with sounds, probes, and expanding devices, and of finger fracture by open surgery, have been known for a long time.
In 1910, transvesical digital dilatation of the prostate was described by Hollingsworth.(40) Frank (41) reported good results with the same technique in 1938. In 1956, Deisting (42) described a dilatation technique that gained some popularity for a time in Scandinavia. He used a modified metal dilator that was first designed by Mercier in 1984.(43) However, the ingenious initial adaptation of modern balloon technology to prostatic obstruction and the courageous self-experimentation must go to Dr. H. Joachim Burhenne of Vancouver, British Columbia. (26) His experiments on dogs and human cadavers suggested the use of this procedure in patients. Using more sophisticated fluoroscopic positioning techniques, larger balloons, and pressure monitoring devices, Castaneda and his co-workers, (44-45) among others, advanced Burhenne's work. Their associates, Reddy and Hulbert (27, 45) at the University of Minnesota, were the first urologists to adopt the technique and provide the first guidelines in patient selection and interpretation of the results. Dowd,(30) at the Lahey Clinic in Massachusetts also has been one of the pioneers in applying balloon dilatation technology for the treatment of symptomatic BPH in one of the largest clinical trials. His work on histopathologic changes on human prostate pre- and post-balloon dilatation is commendable. A silver stain of prostatic tissue is shown before and after balloon dilatation (Fig. 1). The derangement and destruction of the normal prostatic fibers are evident.
Balloon Technology
Three balloon dilatation catheters have been approved by the Food and Drug Administration for the treatment of BPH. The Optilume catheter (American Medical Systems, Minnetonka, MN) is a 14 gauge catheter 50 cm long and accommodates a 0.038 inch guidewire. The dilating balloon is 4 cm long, inflates to 90 F and exerts 4 atmospheres of pressure on the enlarged prostate. The dilating balloon has radiopaque markers at either end. The distal end of the dilating balloon has a palpable prominence called the locator. A second balloon, the fixation balloon, is located 1.5 cm distal to the dilating balloon, and inflates to 40 F. The fixation balloon has a radiopaque marker at its proximal end. The dilating balloon is covered with a silicone sheath to enable an atraumatic withdrawal of the deflated balloon catheter.
The Uroplasty System (Advanced Surgical Interventions, Inc., San Clemente, CA) utilizes a regular 21 F sheath cystoscope set-up. The balloon dilatation begins with measurement of the length of the prostatic urethra. A catheter designed for this purpose has marks at 1-cm intervals that are seen directly via the cystoscope. The calibration catheter balloon is inflated with 10 cc of sterile fluid and positioned against the bladder neck without traction. The distance from the bladder neck to the external sphincter is determined by counting the 1-cm markings on the calibration catheter. The appropriate length dilation catheter then is selected to match this measurement. The 26 F sheath with obturator is passed into the bladder and the obturator is removed. The high pressure, larger diameter balloon catheter is advanced to the first mark on the shaft, which places the distal tip of the catheter beyond the end of the sheath within the bladder so that the Foley balloon can be inflated with 10 to 15 cc of fluid. (28) The dilating balloon is appropriately positioned in the prostatic fossa and inflated to 25 mm (75 F) at 3 atm of pressure. During the initial inflation, mild traction must be applied to overcome the tendency of the catheter to slip forward into the bladder, (28) as is the tendency of other catheters as well.
The Dowd Prostatic Balloon Dilatation Catheter (Microvasive, Watertown, MA) is a noncompliant balloon, 5 cm in length, made of a blend of polyesters (Fig. 2A). The dilating balloon is rectilinear, having relatively squared shoulders. Its resilient texture is capable of withstanding 3,040 mm Hg, or 4 atm, of internal pressure when maximally distended. The dilating capacity is 30 mm, or 90 F, which must be reached and constantly maintained during ten to fifteen minutes. The catheter has a positioning nodule 8 mm proximal to the apical margin of the almost square-shouldered dilating balloon (Fig. 2B). The primary focus of the positioning nodule is to allow for precise, easily confirmed position of the balloon prior to inflation. Additionally, it provides a simple mechanism to maintain confirmation of balloon position during the entire procedure.
Anesthesia
Transurethral dilation of the prostate is painful. Although the prostate gland does not contain many sensory fibers, the prostatic capsule is abundantly innervated with sensory fibers from the pelvic plexus that traverses along the dorsal lateral aspect of the prostate and rectum. (46) Stretching of the prostate capsule during dilatation causes an intense desire to void. Various techniques have been used to prevent or minimize patient discomfort during balloon dilatation. Reddy (47) described an elegant technique with perineal injection of local anesthesia to anesthetize the prostate. Others prefer intraurethral 2 percent lidocaine hydrochloride, short-acting spinal, or light general anesthesia. We found in our setting that 13 percent of the patients preferred complete comfort for which a general anesthetic, or short-acting spinal, was administered. Eighty-seven percent of the patients, however, received 60 cc of 2 percent lidocaine jelly into the urethra and intravenous fentanyl citrate and midazolam hydrochloride (Versed) with good results.
Technique
The technique that we have used involves the Dowd Prostatic Balloon Dilatation Catheter. We prefer to perform the procedure with the patient in the supine position. After a suitable level of anesthesia is achieved, a flexible cystourethroscopy is performed to identify the external sphincter. The bladder is carefully inspected to rule out any bladder pathology. Under fluoroscopic control, an 18 or 20 gauge needle is placed in the skin to mark the external sphincter. Using an 18 F Councill catheter (or 8 F feeding tube), a retrograde urethrogram is performed to confirm the placement of the needle. Using a 0.038-inch floppy tip, a guidewire is introduced via the Councill catheter. The Councill catheter is withdrawn and the balloon catheter is placed over the guidewire. Generous lubricating jelly is applied to the catheter.
The balloon is then inflated to 4 atm of pressure using a pressure gauge for a total of ten to fifteen minutes. The catheter has a positioning nodule 8 mm proximal to the apical margin of the almost square-shouldered dilating balloon. This nodule eliminates the need for fluoroscopy, however, we prefer to use this imaging technique to insure the catheter has not moved. Traction must be applied to overcome the tendency of the catheter to slip forward into the bladder using the traction ring proximal to the catheter. This migration tendency has also been described with other catheters like the Uroplasty System. (28) Monitoring this dilating pressure often reveals that, after approximately five minutes, the prostatic capsule yields to the high pressure which is necessary to add several more milliliters of contrast medium, or saline, using the LeVeen inflator to maintain a constant pressure of 4 atm.
The balloon is then deflated and withdrawn over the guidewire with a counter-clockwise rotary movement to refold the pleats. An 18 F or 20 F Councill catheter is passed over the guidewire. All blood clots are evacuated using normal saline.
We routinely perform a retrograde urethrogram (RUG) or a voiding cystourethrogram (VCU). We think it is important to perform a flexible cystoscopy after the prostate balloon dilatation to confirm the divulsion (or anterior commissurotomy) of the prostatic lobes. The procedure is repeated for another ten minutes if the immediate postoperative results are suboptimal, or if the divulsion pattern is not confirmed. The Foley catheter is left in place for approximately thirty-six hours. The patient is discharged from the hospital with a five- to seven-day supply of oral antibiotics.
Patient Selection
Patient selection has not been completely settled and varies widely among different authors. Patient age has ranged from thirty years (29) to eight-nine years. (30) Urinary peak flow inclusion criteria vary from 2-17 cc/sec (28) to 3-21 cc/sec. (48) Preoperative residual urine fluctuates from 20 cc (32) to 300 cc.(39) The consensus among different authors is to exclude patients with urethral stricture, meatal stenosis, significant middle lobe hypertrophy, curable prostatic malignancy, neurogenic bladder disease, acute prostatitis, or positive urine cultures. Relative exclusion criteria includes medication known to influence vesical or urethral function, and urinary retention.
We believe that prostate weight, although not addressed by some authors, is an important criterion. Our experience indicates that patients with a prostate weight of more than 50 g do not respond as well as patients with gland weight less than 50 g. The configuration of the prostate is also extremely important. The rare predominantly or exclusively middle lobe obstruction is a legitimate exclusionary factor, as was mentioned before. The length of the prostatic urethra has been considered of some importance by other users of prostatic balloons (28-29) The length of the prostatic urethra rarely exceeds 8 cm and, in fact, most reports on prostate balloon dilatation have included patients with a prostatic urethra length fluctuating between 1.5 cm and 4.5 cm (19,29,48)
Patient's age appears also to play an important role. Patients younger than sixty-five years of age appear to be better candidates for balloon divulsion, while patients sixty-seven years of age and older ape pear to have a gradual return of predilatation symptoms during the first year postdilatation.(32)
Complications
Complications of balloon dilatation (divulsion) have been few. In our own series, we have noticed some patients with temporary dribbling incontinence similar to that observed in patients that have undergone transurethral resection of the prostate.(31-32) This finding usually resolved itself within four weeks after transurethral balloon divulsion. Hemorrhage requiring continuous irrigation has been described in few patients; however, no blood transfusion has been necessary.(31-32) Prostatitis is also a potential complication which usually responds to antibiotic therapy. Urinary retention is a possible complication, especially if the Foley catheter is removed too soon, e.g., before 24-48 hours. Reinsertion of the catheter for an additional two to three days usually resolves this problem.
Comment
Balloon dilatation of the prostate represents a nonoperative treatment alternative for treatment of symptomatic BPH. Although some urologists believe that this represents a strong "placebo effect" of treatment, this seems fiercely overrated. One cannot practice medicine for long without being aware of the "placebo effect" in most every therapy you choose, including merely talking with a patient. It is true, however, that placebo-controlled randomized studies are necessary for evaluating treatment modalities. These studies should have an adequate number of patients and a reasonable long-term follow-up to draw any solid conclusion. TUBD offers to a selected patient population several advantages: simplicity, safety, speed, and cost. It may be applied to the limited risk patient. Also, there is minimal hospitalization and convalescence. TUBD does not preclude later definitive treatment. It is less expensive and can be done under local anesthesia. In addition, TUBD has led to neither impotence, incontinence, nor retrograde ejaculation.(32)
The principle disadvantage of the procedure is that its effectiveness may be unpredictable at the present time, as well as the maximum duration of the benefit. I would like to emphasize that there is a definite learning curve with balloon dilatation. It is only when the balloon is positioned exactly within the prostatic fossa that optimal results can be obtained. TUBD is by no means better than TURP; however, balloon divulsion has a place in the management of prostatism. Many questions can be raised, but no one can deny the obvious benefit of TUBD. In any event, we urologists remain as the only physicians who are equipped cognitively to study the pathophysiology of BPH and who must work out the definitive position of TUBD in the urologic arsenal.
Department of Urology Lincoln Hospital 2-A7, 234 E. 149 Street, Bronx, New York 10451 (DR. HERNANDEZ-GRAULAU)
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