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Balloon dilation of prostatic urethra
SCIENTIFIC ARTICLES
BALLOON DILATION OF PROSTATIC URETHRA JAMES D. DAUGHTRY, M.D. BRUCE A. RODAN, M.D. WILLIAM J. BEAN, M.D. From the Departments of Urology and Radiology, Palm Beach Martin County Medical Center, Jupiter, and Palm Beach Gardens Imaging Center, Palm Beach Gardens, Florida
ABS TBA C T--Retrograde balloon catheter dilation of the prostatic urethra was performed for the management of bladder outlet obstruction secondary to prostatic hyperplasia. (9] the 55 patients in our series, 43 were treated entirely as outpatients and 12 were inpatients for unrelated conditions. The patient selection was limited to older, high-risk patients who were poor surgical candidates for •transurethral resection of the prostate or suprapubic prostatectomy because of underlying medical problems. Twenty-two of these patients had Foley catheters for relief of their outflow obstructions. The procedures were performed under local anesthesia or intravenous sedation. Successful results : were noted in 46 of 55 patients with relief of symptoms for up to twenty-six months. In 9 cases the procedures were unsuccessful and transurethral resection of the prostate was required.
The traditional management of prostatic hyperplasia includes transurethral resection of the prostate, suprapubie prostatectomy, or incision of the prostate. 1,2Retrograde balloon dilation of the prostatic urethra was initially described by Burhenne, Chisholm and Quenville. 3 Balloon catheters have been used for nephrostomy tract dilation, ureteral and urethral strictures, and dilation of the intramural ureter prior to ureteral pyeloscopy.4,~ More reeently balloon dilation has been expanded to include retrograde dilation of the prostatic urethra. 5-8 We have performed this procedure on 55 patients, primarily on an outpatient basis. We have used balloon catheters with diameters of 20 ram, 25 mm, 27 mm, 30 mm, and 35 mm to dilate the prostatic fossa and bladder neck in a retrograde approach. Objective improvements of the symptoms were documented with uroflow studies. The patients' stated symptomatic improvements were recorded. Material and Methods We have treated 55 patients with balloon eatheter dilation of the prostatic fossa from July
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1987 through March 1989. The ages range from sixty-six years to ninety-six years (average 81.4 years). All of the patients presented with longstanding symptoms of urinary flow obstruction as noted by hesitancy, intermitteney, urgency, frequency, post void dribbling, and noeturia. Voiding flow patterns were obtained on all patients who did not have Foley catheter drainage and who were able to void adequately. Twelve of the patients had a history of a prior transurethral resection of the prostate three to twenty years prior to the balloon dilation for their obstructive symptoms. Nine of the patients had a history of c a r c i n o m a of the prostate as diagnosed by needle biopsy of the prostate. The preprocedure workup included voiding flow rate, excretory urography, and screening eystoseopie examination. The patients were chosen for the study because they were older age patients who were high-risk, poor surgical candidates with underlying medical conditions. The procedures were performed on an outpatient basis except for patients who were in the hospital for unrelated conditions. Patients with a history of chronic prostatitis or urinary tract
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FIGUI/E 1. (A) Flexible endoscope within urethra identifies position of external sphincter and allows placement of guide wire into bladder without risk of subintimal passage. (t?) Using fluoroscopic guidance, balloon catheter is inserted over guide wire and positioned proximal to external sphincter. (C) Initial inflation of balloon catheter demonstrates "waist" at site of narrowed prostatic urethra. (D) Increasing inflation pressure to 52 psi for ten minutes results in complete prostatic urethral dilation, shown by uniform balloon contour. (E) After dilation, 22F Foley catheter is passed over guide wire and positioned with bladder. infections were treated for seven days with antibioties prior to dilation. Sterile urine was a prerequisite. Technique (Fig. 1) The patients were admitted to the fluoroscopic special procedure room from the ambulatory area. Gentamiein 80 mg and ampieillin 1 g were administered intravenously thirty minutes prior to the procedure, and sedation was given during the procedure, if necessary. With the pa-
204
tient placed in the supine position, a retrograd~ ; urethrogram was performed to identify the external sphincter. Iodinated contrast mediuN~ was diluted with equal parts of 1% lidoeaine. ~i!I 2% viscous lidocaine jelly was injected retrO ~ grade into the urethra A flexible endoscope)! was used for visualization and documentation!
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VOLUME XXXVI, NUMBEIq;~
of tile external sphincter as well as for visually guided passage of the 0.038 Newton LT guide Wire into the bladder. The location of the ex4ernal sphincter was related to the bony pelvis landmarks or external metallic marker. In our series, balloon catheters (20 mm, 25 ram, 27 ram, 30 mm, 35 ram) were utilized. 'he balloon catheter was passed over the guide wire and positioned within the prostatic fossa proximal to the external sphincter. Fluoroscopic guidance was used to check for proper positioning of the balloon catheter prior to ohnd cluring inflation. The balloon was inflated to 52 si and left inflated for ten to fifteen minutes. ~iConstant monitoring of the inflation pressure !was maintained throughout the procedure. The icatheter was then deflated and withdrawn ilwhile rotating in a clockwise fashion to facilitate removal without trauma to the urethral mucosa. All catheter manipulations were con!~ducted under fluoroscopic guidance to insure ~laeement of the balloon catheter proximal to :'the external sphincter, complete dilation of the iprostatie urethra, and adequate deflation prior :o removal. A flexible endoscope was used to re~examine the prostatic fossa prior to Foley eathei~ter insertion. A three-way 22F Silastie Councill ;.tip Foley catheter was inserted over the guide wire. The entire procedure takes approximately thirty minutes to perform. The patient is trans!ferred to the recovery room for observation and irrigation of the Foley catheter if gross hematuria is noted. The Foley catheter is left in place for three to five days to allow resolution of e d e m a and clearing of the urine. i Patients excluded from the study include !those with large post void residuals in excess of !_475 cc and median lobe or marked lateral lobe i extension of the prostate into the bladder. Large i,prostate glands in excess of 40 g were exeluded '~as well as patients with infected urine. Severe ~!trabeculation of the bladder or signs of bladder decompensation or neurogenic bladder dysI function were excluded from the study as were :patients on anticoagulation therapy or with ::bleeding eoagulopathies.
~
t~p
Results Forty-six of the 55 patients who underwent balloon dilation of the prostatic urethra experienced moderate to marked symptomatic improvement as noted by decreased hesitancy, intermitteney, decreased nocturnal frequency, and improved peak and mean flow patterns.
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TABLE I. Balloon dilation of prostatic urethra in 55 patients Case No.
Age (yrs)
1 2 3 4 5 6 7 8 9 l0 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
82 75 85 87 83
78 66 79 68 86 78 84 88 91 80 84 80 74 79 73 84 77 84 87 83 78 80 74 96 7i 78 84 84 73 89 73 70 78 80 82 72 82 91 67 67 75 66 71 92 88 79 84 78 82 80
Prost. Size (g)
Balloon Size (mm)
Inflation Time (rain)
Clin. Outcome
30 30 40 25 . . 38 . . . . 22 28 25 . . __ 23 40 28 . . . . . . . . . . 21 __ 32 25 30 __ 25 . . __ 40 . .
20 20 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 25 27 27 27 27 27 27 25 25 30 35 30 30 30 30 30 30 30 30 30 30 30 30 35 35 35 35 35 35 35 35
10 10 10 10 10
Failure Excellent Good Excellent Excellent
32 . . 25 22 30 35 30 . . . . 38 28 . . . . . . 38 28 . . . . 25 35 40
i0
Good
10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 l0 10 10 10 10 I0
Good Failure Failure Failure Failure Failure Good Fair Excellent Good Good Good Excellent Good Fair Excellent Fair Good Excellent Good Fair Excellent Good Fair Fair Good Failure Fair Fair Good Fair Fair Good Failure Excellent Good Fair Good Excellent Fair Excellent Fair Good Fair Good Good Fair Good Failure
i0 I0 10 10 10 10 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 i5
Table I presents the distribution of the patients' ages, the estimated prostatic size evaluated by transrectal ultrasound, the diameter of the dilating balloon catheter, inflation time of
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205
TABLE II. Case No.
Preop.
1 2 3
R 9/6 9/3
4
7/2.5
5 6A B 7 8 9 10 11 12 13 14 15 16A B 17 18 19 20 21A B
7/5 R 25/5 21/6.5 7/4.4 6/2 10/2 7/3 R R 24/5.7 R 11/3.5 15/5 8/4.5 45/8.5 R 7/6 R R
22 23
12/3.5 R
24 25 26 27A B 28 29 30 31 32 33 34 35 36 37 38 39 4O 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
19/3 16/5 28/7 14/3 18/4.6 7/3 t/ 13 :R 13 R R R
25/8 13/4 23/3.6 25/8 R 28/4
4/2 7/3.5 45/8.5 R R 15/7 R
20/5 R R 28/4.5
23/4 22/7.5 R
0-5 Months
Uroflow rates in 55 patients
Uroflow Rates (Peak/Mean cc/s) 5-10 10-15 15-20 Months Months Months
R 40/10
20/10 22/10 50/10 24/10 16/7 8/15 17/8 R
27/8.3 37/9.5 15/5 45/5
20/10
20-25 Months
25 + Months 36/12
48/10
38/11
21/11
16/10 30/10 25/5 17/8.5 32/8 9/8.3
52/13 33/13
23/8.5
53/10.5
20/10
22/7.5
25/5
55/3 12/3
10/8 31/5
10/4.4 15/5
55/10 34/8.4
55/11 33/9
43/12
24/7
19/7 25/9 16/5 20/5 20/8
15/10 15/10 15/10
18/10 17/8.5
10/7.5
20/8 30/8.5 24/10
25/7 16/10 10/5 18/4.6
42/12 48/12
44/18 50/18
17/5 25/13
50/7
12/7
12/9
40/12 15/9
18/11
40/9
46/11
32/11
50/13 21/13 13/6
65/14
10/5
20/7
17/12
22/10 18/5
15/8
50/10 39/10 50/11.5 38/10 34/10
32/8
KEY:tl = retention.
206
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TABLEIII, Balloon Diameter (mm) 20 25 27 30 35
Relation of inflating balloon diameters to success of procedure
No. of Pts.
Failure
2
1 (50)
3 28 13
1 (33) 4 (14) 1 (8) 1 (11)
9
the balloon during urethral distention, and the clinical outcome determined by the objective and subjective criteria. The mean age of patients in our series was 81.4 years (range 66 to 96 years). The mean prostatic size was 30.4 g (range 20 to 40 g). We utilized five various sizes of balloons to dilate the prostatic urethra. Initially a 20-mm diameter balloon was utilized on our first 2 patients. Subsequently, we used 25-mm diameter balloons (3 patients), 27 m m balloons (28 patients), and 30 m m balloons (13 patients). The last 8 patients plus one earlier underwent dilation using 35-mm diameter balloons. The inflation time of the balloon catheter was monitored by the anesthesiologist. The first 37 patients were dilated for ten minutes and the remainder for fifteen minutes. The objeetive elinieal outcome was determined by follow-up uroflow studies w h e n available. The data are incomplete due to our older patient population. Some patients refused • follow-up studies since they were symptomatically improved, bedridden, or incapacitated. ~,Several of the patients died during the follow!)up period. The subjective criteria of improveqment was based on interviewing the patients ! jduring repeat office visits. ! : Table II presents the uroflow rate both pre~?operative and during the follow-up period, up :::to twentv-six months. Twenty-two patients (40 %) initially presented in urinary retention. ~;hll the patients had mean flow rates of 10 ec per !!:!~eeondor less. Four patients had the procedure ,i!performed twice; 1 patient needed the balloon ~i!dilation performed two months after the initial ~!~attempt due to little symptomatic improve.....raent. Three other patients had satisfactory results for over a year prior to necessitating a repeat procedure. None of the 4 patients have required further intervention at this time. Table III relates inflating balloon diameters to the success rate of the procedure. With the larger diameter balloons, where a number of
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Number (%) Fair Good ..
7 i25) 5 (38) 4 (44)
Exeellent 1 (50)
1'(33) 11 (39) 4 (31) 4 (44)
1 (33) 6 (21) 3 (23) ..
procedures were performed, there appeared to be no significant difference between a fair or excellent outcome as related to balloon dilation. Nine patients (16%) w e r e classified as failures because they subsequently needed transurethral resection of the prostate (TURP). One patient experienced an episode of urinary retention five days following balloon dilation. In another patient who was bedridden with congestive heart failure urinary retention developed sixteen days following balloon dilation. The other patients had only minimal improvements in the voiding flow patterns and had a TURP some months later. A third had a TURP three weeks following dilation which also proved to be unsuccessful. Five of the 9 patients categorized as failures (55 % ) presented in urinary retention. Of the 23 patients who presented in urinary retention, 4 were failures (17%) and 19 were successes (83 % ). The failures did not appear to be related to patient's age or balloon diameter. The 5 failures who did not present in urinary retention had very low mean flow rates averaging 2.85 ce per second (range 2 to 4.4 cc/s). Mild hematuria was a frequent finding after balloon dilation. In 2 cases, bleeding was a problem. One patient was seen in the emergency room with irrigation of clots from the bladder seventy-two hours after the procedure. The patient later admitted to having taken an aspirin compound prior to and after the procedure. The other patient had unexplained prolonged hematuria for five days. None of the patients required blood transfusions or hospital admission. One patient reported a single episode of hematospermia. No post procedure urinary tract infections were noted. None of the patients complained of undue nausea, vomiting, or pain. Comment Traditional therapy for patients with symptoms referable to prostatic enlargement included
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207
suprapubic prostatectomy, transurethral resection of the prostate, and transurethral incision of the prostate. We report on the application of a technique of balloon dilation to the prostatic urethra that is frequently used in other locations of the genitourinary traet, i.e., ureter, urethra, nephrostomy tract, as well as vascular and biliary tree. 9-12 Suceessful treatment depends on correct placement of the balloon eatheter, adequate dilation of the prostatic urethra, and post-procedural stenting. Adequate dilation is necessary for long-term effectiveness. In our series, initial balloon dilation to 20 mm was unsuccessful in 1 of 2 patients. A previous report by Burhenne e t al. 3 with dilation to 8 mm resulted in a favorable result of obstructive symptoms in a single reported case without long-term follow-up. We currently dilate to 35 mm without significant patient diseomfort. Dilation for ten to fifteen minutes at 52 psi has resulted in adequate dilation of the prostatic fossa. Correct placement of the balloon catheter under fluoroscopic guidance is necessary to prevent undue dilation of the external sphincter. The retrograde urethrogram and flexible cystoscope delineate the external sphincter in referenee to the bony architecture. None of our cases has resulted in incontinence or impotenee. These symptoms have been reported following surgical prostatectomies.13 Deflation and repositioning of the balloon catheter may result in damage to the prostatic variees with extensive bleeding. Excessive bleeding was experienced in only 2 of our patients, one associated with aspirin therapy and the other who had unexplained prolonged hematuria. Stenting with a Silastie Foley catheter after balloon dilation of the prostatic urethra maintains the increased patency caliber as well as allowing for irrigation. Three to five days of stenting allows resolution of the edema and swelling prior to Foley catheter removal. The flexible endoscope is utilized to prevent subintimal passage of the guide wire and to identify the external sphincter prior to balloon placement and dilation. The indiscriminate passage of a guide wire with the inadvertent subintimal passage of the guide wire and balloon may result in urinary incontinence. We have not been concerned with prolonged hematuria. In several instances the Foley catheter was left in place for seven to ten days. All of the outpatients were sent home with Foley catheters connected to a drainage bag. The 208
hospital's visiting nurse service provided instructions to older patients and visited patients on a daily basis and removed the Foley eatheter after three days or when the urine cleared. Hand irrigation of the Foley is occasionally required and was done by the visiting nurse service exeept in two instanees in whieh the patient returned to the emergency room with an obstructed catheter. There was close follow-up at two weeks with repeat voiding flow rates obtained when possible. Several of our patients were lost to followup or they died. None of the patients under, went cystoscopy or instrumental examination following the procedure except for the 9 failures that subsequently required TURR The majority of the patients in this series were followed up by voiding flow patterns and by recording their symptomatic improvement. The 20-mm bal' loon does not appear to be adequately suited for this procedure and is an adaptation of a balloon used for esophageal dilation. The 25- to 35-mm balloons appear to be suitable for this proee,: dure, and the patients successfully treated have: noted marked improvement of their obstructive symptoms as well as their voiding flow pat, terns. Our preference is to use the 35-mm bal, loon to obtain maximal dilation of the prostatie fossa. During the first thirty days following the proeedure, many patients experieneed only mild improvement in their symptoms and voiding flow patterns over the next three to six months. Most patients had experienced a progressive improvement in their obstructive symptoms. Recent reports with follow-up: magnetic resonance imaging (MBI) of patients: after balloon dilation suggest that prostatic: hemorrhage and resulting fibrosis of the hyper;i plastic tissue result in decrease in prostatic size: eompared with predilation size. The prostate; capsule and immediate surrounding tissue: never appeared to be altered by balloon dila~ tion. 14 Prostatic dilation may result in intra,:' prostatic hemorrhage and/or edema, acute prostatic enlargement that remains for weeksl and sometimes prostatic shrinkage, possible as a result of fibrosis. Disruption of the tissue out~ side the prostate has not been seen by MRI. Summary In our series, our success rate is due in part to :: careful patient selection. We excluded patients with predominant median lobes, large bladder
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residuals with bladder deeompensation, neurogenic bladder dysfunction, patients with lateral lobe extension into the bladder, or prostates larger than 40 g. We have limited ourselves to patients with urine residuals of less than 475 cc. Sterile urine was a prerequisite. The 9 failures that occurred in our series may have occurred because of inadequate balloon size, balloon positioning, inflation time, or inadequate stenting to allow swelling and edema to resolve. We believe this procedure may have expanded applications beyond the poor surgical risk patients in our series. Balloon dilation of the prostatic urethra may be the initial treatment of choice for patients with obstructive symptoms when adequate studies have been performed and information regarding balloon size, pressure, stenting time, and long-term effects of the prostate become available. To date, the procedure is well tolerated, can be performed in an outpatient setting, has low morbidity, and has not required any general anesthesia. Blood transfusions and hospitalization do not appear to be required. Performing the balloon dilation does not preclude the performance of a TURP as a subsequent procedure, if needed. Balloon dilation of the prostatic fossa may provide immediate relief of obstruction in individuals with prostatic carcinoma. Prostate ultrasound and biopsy may be indicated prior to balloon dilation to rule out cancer of the prostate. Balloon dilation may be the procedure of choice for patients with prostate carcinoma and obstructive symptoms who undergo intervention, i.e., hormonal manipulation or bilatera] orchiectomy. ~5 Medical treatment in the form of alphaadrenergic blockers may offer some short-term relief of obstruction while edema and fibrosis of the prostate gland are occurring. TM Transient hematuria was the only significant complication recorded in our series. Since transurethral
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balloon dilation appears to be a simple, inexpensive, and relatively risk-free treatment modality for symptomatic benign prostatic hypertrophy, a large prospective study with a long-term follow-up is warranted. 1210 South Old Dixie Highway ]upiter~ Florida 33458 (DR. DAUGHTRY) References 1. Orandi A: Transurethral incision of the prostate, J Urol I10: 229 (1973). 2. Edwards L, and Powell C: An objective comparison of transurethral resection and bladder neck incision in the treatment of prostatic hyperplasia, J Urol 128:325 (1982). 3. Burhenne AJ, Chisholm RJ, and Quenville NF: Prostatic hyperplasia: radiological intervention, Radiology 152:655 (1984). 4. Daughtry JD, Bean WJ, Redan BA, and Mullin DM: Balloon dilation of the ureter: a means to facilitate the passage of ureteral and renal calculi, J Urol 136:1063 (1986). 5. Daughtry JD, Redan BA, and Bean WJ: Balloon dilation of urethral strictures, Urology 31:231 (1988). 6. Castaneda F, et ah Benign prostatic hypertrophy: retrograde transurethral dilation of the prostatic urethra in humans, Radiology 163:649 (1987). 7. Castaneda P, et al: Retrograde prostatic urethroplasty with balloon catheter, Sere Intervent Radiol 4:115 (1987). 8. Mohammed H, and Wirima J: Balloon catheter dilatation of urethral strictures, AJR 150:327 (1988). 9. Smith AD, et ah Percutaneous nephrostomy in the management of ureteral and renal calculi, Radiology 133:49 (1979). 10. Clayman RV, et ah Rapid balloon dilatation of the nephrostomy tract for nephrostolithotomy, Radiology 147:884 (1983). 11. Wierny L, Plass R, and Postmann W: Long-term results in 100 consecutive patients treated by transluminal angioplasty, Radiology 112:543 (1974). 12. Burhenne H], and Morris DC: Biliary stricture dilatation: use of the Gruntzig balloon catheter, J Can Assoc Radiol 31:196
(1980).
13. Melchoir J, et ah Transurethral prostatectomy: compterized analysis of 2,223 consecutive cases, J Urol 112:634 (1974). 14. Johnson S, et al: Magnetic resonance imaging of patients after balloon dilatation of the prostate, presented at American Roentgen Ray Society Meeting, California, San Francisco, May, 1988. 15. Wendel EF, et ah The effect of orchiectomy and estrogens on benign prostatic hyperplasia, J Urol 108:116 (1972). 16. Fleischmann JD, and Catalona WJ: Endocrine therapy for bladder outlet obstruction from carcinoma of the prostate, J Urol 134:498 (1985).
VOLUME XXXVI, NUMBER 3
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BALLOON DILATION OF PROSTATIC URETHRA JAMES D. DAUGHTRY, M.D. BRUCE A. RODAN, M.D. WILLIAM J. BEAN, M.D. From the Departments of Urology and Radiology, Palm Beach Martin County Medical Center, Jupiter, and Palm Beach Gardens Imaging Center, Palm Beach Gardens, Florida
ABS TBA C T--Retrograde balloon catheter dilation of the prostatic urethra was performed for the management of bladder outlet obstruction secondary to prostatic hyperplasia. (9] the 55 patients in our series, 43 were treated entirely as outpatients and 12 were inpatients for unrelated conditions. The patient selection was limited to older, high-risk patients who were poor surgical candidates for •transurethral resection of the prostate or suprapubic prostatectomy because of underlying medical problems. Twenty-two of these patients had Foley catheters for relief of their outflow obstructions. The procedures were performed under local anesthesia or intravenous sedation. Successful results : were noted in 46 of 55 patients with relief of symptoms for up to twenty-six months. In 9 cases the procedures were unsuccessful and transurethral resection of the prostate was required.
The traditional management of prostatic hyperplasia includes transurethral resection of the prostate, suprapubie prostatectomy, or incision of the prostate. 1,2Retrograde balloon dilation of the prostatic urethra was initially described by Burhenne, Chisholm and Quenville. 3 Balloon catheters have been used for nephrostomy tract dilation, ureteral and urethral strictures, and dilation of the intramural ureter prior to ureteral pyeloscopy.4,~ More reeently balloon dilation has been expanded to include retrograde dilation of the prostatic urethra. 5-8 We have performed this procedure on 55 patients, primarily on an outpatient basis. We have used balloon catheters with diameters of 20 ram, 25 mm, 27 mm, 30 mm, and 35 mm to dilate the prostatic fossa and bladder neck in a retrograde approach. Objective improvements of the symptoms were documented with uroflow studies. The patients' stated symptomatic improvements were recorded. Material and Methods We have treated 55 patients with balloon eatheter dilation of the prostatic fossa from July
UROLOGy
SEPTEMBEtl 1990
/
1987 through March 1989. The ages range from sixty-six years to ninety-six years (average 81.4 years). All of the patients presented with longstanding symptoms of urinary flow obstruction as noted by hesitancy, intermitteney, urgency, frequency, post void dribbling, and noeturia. Voiding flow patterns were obtained on all patients who did not have Foley catheter drainage and who were able to void adequately. Twelve of the patients had a history of a prior transurethral resection of the prostate three to twenty years prior to the balloon dilation for their obstructive symptoms. Nine of the patients had a history of c a r c i n o m a of the prostate as diagnosed by needle biopsy of the prostate. The preprocedure workup included voiding flow rate, excretory urography, and screening eystoseopie examination. The patients were chosen for the study because they were older age patients who were high-risk, poor surgical candidates with underlying medical conditions. The procedures were performed on an outpatient basis except for patients who were in the hospital for unrelated conditions. Patients with a history of chronic prostatitis or urinary tract
VOLUME XXXV1, NUMBER 3
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: :ii
FIGUI/E 1. (A) Flexible endoscope within urethra identifies position of external sphincter and allows placement of guide wire into bladder without risk of subintimal passage. (t?) Using fluoroscopic guidance, balloon catheter is inserted over guide wire and positioned proximal to external sphincter. (C) Initial inflation of balloon catheter demonstrates "waist" at site of narrowed prostatic urethra. (D) Increasing inflation pressure to 52 psi for ten minutes results in complete prostatic urethral dilation, shown by uniform balloon contour. (E) After dilation, 22F Foley catheter is passed over guide wire and positioned with bladder. infections were treated for seven days with antibioties prior to dilation. Sterile urine was a prerequisite. Technique (Fig. 1) The patients were admitted to the fluoroscopic special procedure room from the ambulatory area. Gentamiein 80 mg and ampieillin 1 g were administered intravenously thirty minutes prior to the procedure, and sedation was given during the procedure, if necessary. With the pa-
204
tient placed in the supine position, a retrograd~ ; urethrogram was performed to identify the external sphincter. Iodinated contrast mediuN~ was diluted with equal parts of 1% lidoeaine. ~i!I 2% viscous lidocaine jelly was injected retrO ~ grade into the urethra A flexible endoscope)! was used for visualization and documentation!
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VOLUME XXXVI, NUMBEIq;~
of tile external sphincter as well as for visually guided passage of the 0.038 Newton LT guide Wire into the bladder. The location of the ex4ernal sphincter was related to the bony pelvis landmarks or external metallic marker. In our series, balloon catheters (20 mm, 25 ram, 27 ram, 30 mm, 35 ram) were utilized. 'he balloon catheter was passed over the guide wire and positioned within the prostatic fossa proximal to the external sphincter. Fluoroscopic guidance was used to check for proper positioning of the balloon catheter prior to ohnd cluring inflation. The balloon was inflated to 52 si and left inflated for ten to fifteen minutes. ~iConstant monitoring of the inflation pressure !was maintained throughout the procedure. The icatheter was then deflated and withdrawn ilwhile rotating in a clockwise fashion to facilitate removal without trauma to the urethral mucosa. All catheter manipulations were con!~ducted under fluoroscopic guidance to insure ~laeement of the balloon catheter proximal to :'the external sphincter, complete dilation of the iprostatie urethra, and adequate deflation prior :o removal. A flexible endoscope was used to re~examine the prostatic fossa prior to Foley eathei~ter insertion. A three-way 22F Silastie Councill ;.tip Foley catheter was inserted over the guide wire. The entire procedure takes approximately thirty minutes to perform. The patient is trans!ferred to the recovery room for observation and irrigation of the Foley catheter if gross hematuria is noted. The Foley catheter is left in place for three to five days to allow resolution of e d e m a and clearing of the urine. i Patients excluded from the study include !those with large post void residuals in excess of !_475 cc and median lobe or marked lateral lobe i extension of the prostate into the bladder. Large i,prostate glands in excess of 40 g were exeluded '~as well as patients with infected urine. Severe ~!trabeculation of the bladder or signs of bladder decompensation or neurogenic bladder dysI function were excluded from the study as were :patients on anticoagulation therapy or with ::bleeding eoagulopathies.
~
t~p
Results Forty-six of the 55 patients who underwent balloon dilation of the prostatic urethra experienced moderate to marked symptomatic improvement as noted by decreased hesitancy, intermitteney, decreased nocturnal frequency, and improved peak and mean flow patterns.
UROI,()Gy
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SEPTEMBER 1990
/
TABLE I. Balloon dilation of prostatic urethra in 55 patients Case No.
Age (yrs)
1 2 3 4 5 6 7 8 9 l0 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
82 75 85 87 83
78 66 79 68 86 78 84 88 91 80 84 80 74 79 73 84 77 84 87 83 78 80 74 96 7i 78 84 84 73 89 73 70 78 80 82 72 82 91 67 67 75 66 71 92 88 79 84 78 82 80
Prost. Size (g)
Balloon Size (mm)
Inflation Time (rain)
Clin. Outcome
30 30 40 25 . . 38 . . . . 22 28 25 . . __ 23 40 28 . . . . . . . . . . 21 __ 32 25 30 __ 25 . . __ 40 . .
20 20 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 27 25 27 27 27 27 27 27 25 25 30 35 30 30 30 30 30 30 30 30 30 30 30 30 35 35 35 35 35 35 35 35
10 10 10 10 10
Failure Excellent Good Excellent Excellent
32 . . 25 22 30 35 30 . . . . 38 28 . . . . . . 38 28 . . . . 25 35 40
i0
Good
10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 l0 10 10 10 10 I0
Good Failure Failure Failure Failure Failure Good Fair Excellent Good Good Good Excellent Good Fair Excellent Fair Good Excellent Good Fair Excellent Good Fair Fair Good Failure Fair Fair Good Fair Fair Good Failure Excellent Good Fair Good Excellent Fair Excellent Fair Good Fair Good Good Fair Good Failure
i0 I0 10 10 10 10 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 15 i5
Table I presents the distribution of the patients' ages, the estimated prostatic size evaluated by transrectal ultrasound, the diameter of the dilating balloon catheter, inflation time of
VOLUME XXXVI, NUMBER 3
205
TABLE II. Case No.
Preop.
1 2 3
R 9/6 9/3
4
7/2.5
5 6A B 7 8 9 10 11 12 13 14 15 16A B 17 18 19 20 21A B
7/5 R 25/5 21/6.5 7/4.4 6/2 10/2 7/3 R R 24/5.7 R 11/3.5 15/5 8/4.5 45/8.5 R 7/6 R R
22 23
12/3.5 R
24 25 26 27A B 28 29 30 31 32 33 34 35 36 37 38 39 4O 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55
19/3 16/5 28/7 14/3 18/4.6 7/3 t/ 13 :R 13 R R R
25/8 13/4 23/3.6 25/8 R 28/4
4/2 7/3.5 45/8.5 R R 15/7 R
20/5 R R 28/4.5
23/4 22/7.5 R
0-5 Months
Uroflow rates in 55 patients
Uroflow Rates (Peak/Mean cc/s) 5-10 10-15 15-20 Months Months Months
R 40/10
20/10 22/10 50/10 24/10 16/7 8/15 17/8 R
27/8.3 37/9.5 15/5 45/5
20/10
20-25 Months
25 + Months 36/12
48/10
38/11
21/11
16/10 30/10 25/5 17/8.5 32/8 9/8.3
52/13 33/13
23/8.5
53/10.5
20/10
22/7.5
25/5
55/3 12/3
10/8 31/5
10/4.4 15/5
55/10 34/8.4
55/11 33/9
43/12
24/7
19/7 25/9 16/5 20/5 20/8
15/10 15/10 15/10
18/10 17/8.5
10/7.5
20/8 30/8.5 24/10
25/7 16/10 10/5 18/4.6
42/12 48/12
44/18 50/18
17/5 25/13
50/7
12/7
12/9
40/12 15/9
18/11
40/9
46/11
32/11
50/13 21/13 13/6
65/14
10/5
20/7
17/12
22/10 18/5
15/8
50/10 39/10 50/11.5 38/10 34/10
32/8
KEY:tl = retention.
206
UBOLOGY /
SEPTEMBER 1990 / VOLUME XXXVI, NuMBF,It 3:;'~
TABLEIII, Balloon Diameter (mm) 20 25 27 30 35
Relation of inflating balloon diameters to success of procedure
No. of Pts.
Failure
2
1 (50)
3 28 13
1 (33) 4 (14) 1 (8) 1 (11)
9
the balloon during urethral distention, and the clinical outcome determined by the objective and subjective criteria. The mean age of patients in our series was 81.4 years (range 66 to 96 years). The mean prostatic size was 30.4 g (range 20 to 40 g). We utilized five various sizes of balloons to dilate the prostatic urethra. Initially a 20-mm diameter balloon was utilized on our first 2 patients. Subsequently, we used 25-mm diameter balloons (3 patients), 27 m m balloons (28 patients), and 30 m m balloons (13 patients). The last 8 patients plus one earlier underwent dilation using 35-mm diameter balloons. The inflation time of the balloon catheter was monitored by the anesthesiologist. The first 37 patients were dilated for ten minutes and the remainder for fifteen minutes. The objeetive elinieal outcome was determined by follow-up uroflow studies w h e n available. The data are incomplete due to our older patient population. Some patients refused • follow-up studies since they were symptomatically improved, bedridden, or incapacitated. ~,Several of the patients died during the follow!)up period. The subjective criteria of improveqment was based on interviewing the patients ! jduring repeat office visits. ! : Table II presents the uroflow rate both pre~?operative and during the follow-up period, up :::to twentv-six months. Twenty-two patients (40 %) initially presented in urinary retention. ~;hll the patients had mean flow rates of 10 ec per !!:!~eeondor less. Four patients had the procedure ,i!performed twice; 1 patient needed the balloon ~i!dilation performed two months after the initial ~!~attempt due to little symptomatic improve.....raent. Three other patients had satisfactory results for over a year prior to necessitating a repeat procedure. None of the 4 patients have required further intervention at this time. Table III relates inflating balloon diameters to the success rate of the procedure. With the larger diameter balloons, where a number of
UROI,OGY
/
SEPTEMBER 1990
/
Number (%) Fair Good ..
7 i25) 5 (38) 4 (44)
Exeellent 1 (50)
1'(33) 11 (39) 4 (31) 4 (44)
1 (33) 6 (21) 3 (23) ..
procedures were performed, there appeared to be no significant difference between a fair or excellent outcome as related to balloon dilation. Nine patients (16%) w e r e classified as failures because they subsequently needed transurethral resection of the prostate (TURP). One patient experienced an episode of urinary retention five days following balloon dilation. In another patient who was bedridden with congestive heart failure urinary retention developed sixteen days following balloon dilation. The other patients had only minimal improvements in the voiding flow patterns and had a TURP some months later. A third had a TURP three weeks following dilation which also proved to be unsuccessful. Five of the 9 patients categorized as failures (55 % ) presented in urinary retention. Of the 23 patients who presented in urinary retention, 4 were failures (17%) and 19 were successes (83 % ). The failures did not appear to be related to patient's age or balloon diameter. The 5 failures who did not present in urinary retention had very low mean flow rates averaging 2.85 ce per second (range 2 to 4.4 cc/s). Mild hematuria was a frequent finding after balloon dilation. In 2 cases, bleeding was a problem. One patient was seen in the emergency room with irrigation of clots from the bladder seventy-two hours after the procedure. The patient later admitted to having taken an aspirin compound prior to and after the procedure. The other patient had unexplained prolonged hematuria for five days. None of the patients required blood transfusions or hospital admission. One patient reported a single episode of hematospermia. No post procedure urinary tract infections were noted. None of the patients complained of undue nausea, vomiting, or pain. Comment Traditional therapy for patients with symptoms referable to prostatic enlargement included
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suprapubic prostatectomy, transurethral resection of the prostate, and transurethral incision of the prostate. We report on the application of a technique of balloon dilation to the prostatic urethra that is frequently used in other locations of the genitourinary traet, i.e., ureter, urethra, nephrostomy tract, as well as vascular and biliary tree. 9-12 Suceessful treatment depends on correct placement of the balloon eatheter, adequate dilation of the prostatic urethra, and post-procedural stenting. Adequate dilation is necessary for long-term effectiveness. In our series, initial balloon dilation to 20 mm was unsuccessful in 1 of 2 patients. A previous report by Burhenne e t al. 3 with dilation to 8 mm resulted in a favorable result of obstructive symptoms in a single reported case without long-term follow-up. We currently dilate to 35 mm without significant patient diseomfort. Dilation for ten to fifteen minutes at 52 psi has resulted in adequate dilation of the prostatic fossa. Correct placement of the balloon catheter under fluoroscopic guidance is necessary to prevent undue dilation of the external sphincter. The retrograde urethrogram and flexible cystoscope delineate the external sphincter in referenee to the bony architecture. None of our cases has resulted in incontinence or impotenee. These symptoms have been reported following surgical prostatectomies.13 Deflation and repositioning of the balloon catheter may result in damage to the prostatic variees with extensive bleeding. Excessive bleeding was experienced in only 2 of our patients, one associated with aspirin therapy and the other who had unexplained prolonged hematuria. Stenting with a Silastie Foley catheter after balloon dilation of the prostatic urethra maintains the increased patency caliber as well as allowing for irrigation. Three to five days of stenting allows resolution of the edema and swelling prior to Foley catheter removal. The flexible endoscope is utilized to prevent subintimal passage of the guide wire and to identify the external sphincter prior to balloon placement and dilation. The indiscriminate passage of a guide wire with the inadvertent subintimal passage of the guide wire and balloon may result in urinary incontinence. We have not been concerned with prolonged hematuria. In several instances the Foley catheter was left in place for seven to ten days. All of the outpatients were sent home with Foley catheters connected to a drainage bag. The 208
hospital's visiting nurse service provided instructions to older patients and visited patients on a daily basis and removed the Foley eatheter after three days or when the urine cleared. Hand irrigation of the Foley is occasionally required and was done by the visiting nurse service exeept in two instanees in whieh the patient returned to the emergency room with an obstructed catheter. There was close follow-up at two weeks with repeat voiding flow rates obtained when possible. Several of our patients were lost to followup or they died. None of the patients under, went cystoscopy or instrumental examination following the procedure except for the 9 failures that subsequently required TURR The majority of the patients in this series were followed up by voiding flow patterns and by recording their symptomatic improvement. The 20-mm bal' loon does not appear to be adequately suited for this procedure and is an adaptation of a balloon used for esophageal dilation. The 25- to 35-mm balloons appear to be suitable for this proee,: dure, and the patients successfully treated have: noted marked improvement of their obstructive symptoms as well as their voiding flow pat, terns. Our preference is to use the 35-mm bal, loon to obtain maximal dilation of the prostatie fossa. During the first thirty days following the proeedure, many patients experieneed only mild improvement in their symptoms and voiding flow patterns over the next three to six months. Most patients had experienced a progressive improvement in their obstructive symptoms. Recent reports with follow-up: magnetic resonance imaging (MBI) of patients: after balloon dilation suggest that prostatic: hemorrhage and resulting fibrosis of the hyper;i plastic tissue result in decrease in prostatic size: eompared with predilation size. The prostate; capsule and immediate surrounding tissue: never appeared to be altered by balloon dila~ tion. 14 Prostatic dilation may result in intra,:' prostatic hemorrhage and/or edema, acute prostatic enlargement that remains for weeksl and sometimes prostatic shrinkage, possible as a result of fibrosis. Disruption of the tissue out~ side the prostate has not been seen by MRI. Summary In our series, our success rate is due in part to :: careful patient selection. We excluded patients with predominant median lobes, large bladder
UROLOGY
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SEPTEMBER 1990
/ VOLUME XXXVI, NUMBEtl3;
residuals with bladder deeompensation, neurogenic bladder dysfunction, patients with lateral lobe extension into the bladder, or prostates larger than 40 g. We have limited ourselves to patients with urine residuals of less than 475 cc. Sterile urine was a prerequisite. The 9 failures that occurred in our series may have occurred because of inadequate balloon size, balloon positioning, inflation time, or inadequate stenting to allow swelling and edema to resolve. We believe this procedure may have expanded applications beyond the poor surgical risk patients in our series. Balloon dilation of the prostatic urethra may be the initial treatment of choice for patients with obstructive symptoms when adequate studies have been performed and information regarding balloon size, pressure, stenting time, and long-term effects of the prostate become available. To date, the procedure is well tolerated, can be performed in an outpatient setting, has low morbidity, and has not required any general anesthesia. Blood transfusions and hospitalization do not appear to be required. Performing the balloon dilation does not preclude the performance of a TURP as a subsequent procedure, if needed. Balloon dilation of the prostatic fossa may provide immediate relief of obstruction in individuals with prostatic carcinoma. Prostate ultrasound and biopsy may be indicated prior to balloon dilation to rule out cancer of the prostate. Balloon dilation may be the procedure of choice for patients with prostate carcinoma and obstructive symptoms who undergo intervention, i.e., hormonal manipulation or bilatera] orchiectomy. ~5 Medical treatment in the form of alphaadrenergic blockers may offer some short-term relief of obstruction while edema and fibrosis of the prostate gland are occurring. TM Transient hematuria was the only significant complication recorded in our series. Since transurethral
UROLOGY /
SEPTEMBER 1990 /
balloon dilation appears to be a simple, inexpensive, and relatively risk-free treatment modality for symptomatic benign prostatic hypertrophy, a large prospective study with a long-term follow-up is warranted. 1210 South Old Dixie Highway ]upiter~ Florida 33458 (DR. DAUGHTRY) References 1. Orandi A: Transurethral incision of the prostate, J Urol I10: 229 (1973). 2. Edwards L, and Powell C: An objective comparison of transurethral resection and bladder neck incision in the treatment of prostatic hyperplasia, J Urol 128:325 (1982). 3. Burhenne AJ, Chisholm RJ, and Quenville NF: Prostatic hyperplasia: radiological intervention, Radiology 152:655 (1984). 4. Daughtry JD, Bean WJ, Redan BA, and Mullin DM: Balloon dilation of the ureter: a means to facilitate the passage of ureteral and renal calculi, J Urol 136:1063 (1986). 5. Daughtry JD, Redan BA, and Bean WJ: Balloon dilation of urethral strictures, Urology 31:231 (1988). 6. Castaneda F, et ah Benign prostatic hypertrophy: retrograde transurethral dilation of the prostatic urethra in humans, Radiology 163:649 (1987). 7. Castaneda P, et al: Retrograde prostatic urethroplasty with balloon catheter, Sere Intervent Radiol 4:115 (1987). 8. Mohammed H, and Wirima J: Balloon catheter dilatation of urethral strictures, AJR 150:327 (1988). 9. Smith AD, et ah Percutaneous nephrostomy in the management of ureteral and renal calculi, Radiology 133:49 (1979). 10. Clayman RV, et ah Rapid balloon dilatation of the nephrostomy tract for nephrostolithotomy, Radiology 147:884 (1983). 11. Wierny L, Plass R, and Postmann W: Long-term results in 100 consecutive patients treated by transluminal angioplasty, Radiology 112:543 (1974). 12. Burhenne H], and Morris DC: Biliary stricture dilatation: use of the Gruntzig balloon catheter, J Can Assoc Radiol 31:196
(1980).
13. Melchoir J, et ah Transurethral prostatectomy: compterized analysis of 2,223 consecutive cases, J Urol 112:634 (1974). 14. Johnson S, et al: Magnetic resonance imaging of patients after balloon dilatation of the prostate, presented at American Roentgen Ray Society Meeting, California, San Francisco, May, 1988. 15. Wendel EF, et ah The effect of orchiectomy and estrogens on benign prostatic hyperplasia, J Urol 108:116 (1972). 16. Fleischmann JD, and Catalona WJ: Endocrine therapy for bladder outlet obstruction from carcinoma of the prostate, J Urol 134:498 (1985).
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