BALLOON DILATATION OF PROSTATE: KEYS TO SUSTAINED FAVORABLE RESULTS WILLIAM
G. MOSELEY.
M.D.
From the Department of Urology, Harbor View Medical Center and Sharp Memorial Hospital, San Diego, California ABSTRACT-Seventy-seven patients with small prostates (200 mL ultrasonically determined using Bladder Scan (Diagnostic Ultrasound Corporation, Kirkland, Washington) or of prostate cancer. A total of 77 patients satisfied these criteria and gave informed consent to participation in the study. Their mean age was 64.4 years (range 45 to 95 years), and the average gland size as determined by transrectal ultrasound was 18.49 g (SD 5.76). Patients were evaluated pre-dilatation and at intervals thereafter by both subjective and objective measures. Their symptoms were rated by the Madsen-Iversen scale, with obstructive symptoms being scored a maximum
of 1X and irritative symptoms a maximum of 9. The peak urinary flow rate (PQ) and voided volume were measured using a Urolab 1152 (I,ife-Tech Instruments, Houston, Texas). The adjusted P.sures. bladder neck, and bladder. A lubricated calibration catheter was passed through the cystoscope bridge and positioned in the bladder under direct observation. The Foley balloon on the catheter was inflated and drawn back lightly against the bladder neck. catheter was maintained While the calibration at the vesical neck, the sheath and lens were withdrawn slowly while the operator observed the markings at l-cm intervals along the catheter shaft. The measurement at the distal aspect sphiwtm indicated the length of of tlw rxternul the prostatic urethra and appropriate size dilatation balloon. The calibration catheter was then withdrawn, the bladder was filled, and the sheath and lens were replaced with the introduction sheath and obturator provided with the dilatation balloon catheter. The dilatation catheter was then passed through the sheath into the bladder, and the terminal 15-n1L Foley balloon was inflated and pulled back against the bladder neck. The dilatation ‘balloon was positioned in the prostatic urethra and its position confirnled endoscopitally by observing the white marker band on the catiheter shaft distal and adjacent to the external sphincter. The balloon was inflated to 3 atm of pressllre (45 psi) and maintained for ten minrltes. The sized-to-fit intra-prostatic balloon did not migrate into the bladder, but locked within the prostate during inflation. After dilatation, the balloons were deflated and then withdrawn back into the sheath, protecting the urethra. and the sheath and catheter were removed. The treated area was examined endoscopically to confirm the presence of commissurotomy or divulsion through the fibromuscular stroma (Fig. 1). A Foley catheter was inserted after surgery to prevent urinarv retention from blood clots or edema. All patients were kept overnight on a twenty-three-hour stay and sent home the fol-
1. Anterior ~ornn~i,vsurotoIIl1( clnd tear through fihi-ornusmlar .stroina rfwlting jroin forces gcvwratcd hy .sized-to-jit intra-pmvtatit dilatation halloon. FI(:lJItE:
lowing day with instructions to remove the catheter forty-eight hours later. Cefazolin sodium (Ancef) 1 g was administered intravenously to all patients one hour prior to the operation and ever!’ eight hours postoperatively. Patients received ctephalexin 500 mg bid for five days after treatment. Patients were followed initially at on, with belladonna and opium 60 mg suppositol-irs. l’hcre \\.ere no significant complications and no cases of incontinence, impotencca, retrograde ejaculation. or lrrethral strictures.
AVERAGE PEAK UROFLOW
16
AVERAGE 16-
SYMPTOM
SCORE t
-cl-
OBS
-o--
IRR
-#TOTAL +/- S.E.M.
12$ 8 lo-
!
6-
ffl
6-
1
-.-
I
= MEAN +/- S.E.M.
1
/
I
I
I
0 PRE N ? ?77
I 3M0 N = 43
I 6M0 N : 44
/ 12 MO N=40
PRE n = 72
I 10 MO N : 20
3 MOS n = 57
24 MO N:ll
6 MOS n = 46
FOLLOW-UP
12 MOS n ? ?37
18 MOS n = 18
24 MOS n = 10
(Months)
3. Peak uroflow at various times after BDP Values at three, six, and twelve months are significantly differentfrom pretreatment values at p = 0.0001. Value at eighteen months is significant at p = 0.0225. The p value at twenty-four months (0.4331) is of que.stionable utility because of small number of patients. FIGURE
FOLLOW-UP
(Months)
FIGUHE 2. Average
obstructive (OBS), irritative (IRR), and total symptom scores after BDP Va1ue.s for obstructive, irritative, and total symptoms are significantly different from pretreatment values (p = 0.0001) at all follow-up times.
Of the 43 patients with symptom scores available at three months, 91 percent had obtained at least a 50 percent reduction in their overall score; the average decrease was 12.07 points (Fig. 2). In nearly all cases improvement was maintained over the total length of followup. The average total symptom score declined from 16.47 + 4.35 preoperatively to 4.36 f 3.28 (n = 44) at six months, 4.48 f 3.65 (n = 40) at twelve months, 3.90 f 2.02 (n = 20) at eighteen months, and 3.82 f 1.47 (n = 11) at twenty-four months. In most patients, obstructive symptoms tended to be more responsive than irritative ones, with mean reductions of 80 percent and 47 percent, respectively. In the entire series, the mean symptom score at last follow-up had declined by 70 percent (SD 19%), from 16.47 to 4.65. At last follow-up, 87 percent of patients experienced a 50 percent or greater reduction in symptom score. The uroflow data likewise reflected the utility of BDP At last follow-up, 49 percent of patients experienced a 50 percent or greater increase in PQ. At three months, the patients examined had an average PQ of 14.07 mL/sec vs 8.25 mL/sec preoperatively (Fig. 3). The improvement was maintained at subsequent time periods. The adjusted PQ in the entire series of
316
patients improved from an average of 0.77 + 0.37 pretreatment to 1.19 f 0.63 at three months. There was a slight decline at six months (1.10 k 0.53), after which the adjusted PQ stabilized at approximately 1.14 over the remainder of the study (data not shown). An indication of the natural history of postdilatation BPH can be gained from Table I, wherein is described patients who were seen for all scheduled follow-ups for the first year after dilatation. It is apparent that although most patients had fluctuations in their symptom score, in only 1 patient did the score at twelve months approach the pretreatment value. Initial symptom score reductions remained stable at eighteen and twenty-four months. Comment Early trials of BDP produced inconsistent results,3,4 but through years of clinical experience, balloon dilatation pioneers have retrospectively developed patient selection criteria. Although not all the criteria have been defined, an appropriate candidate for BDP appears to have a small prostate (< 40 g), confirmed obstructive symptomatology, adequate detrusor function, and primary lateral lobe hyperplasia.5 7 General contraindications include a large gland (>40 g), significant middle lobe hyperplasia,
lJHOI>O(;Y
// API200 mL, chronic urinary retention). untreated prostatitis, active urinary tract infection. severe untreated urethral strictures, and prostate cancer.8-g The most extensive clinical experience with balloon technology has been in the arterial system in percutaneous transluminal angioplast): Although it was believed initially that this technique worked by compressing plaque, Castaneda-Zuniga et al. lo pointed out in 1980 that such a mechanism was not plausible, given the nature of artherosclerotic material. In extensive experimental work since, they have shown that successful angioplasty requires stretching of and controlled damage to the outer layers of the arterial wall with fracture of the plaque.” Much the same concept appears to apply to prostatic balloon dilatation. Several of the first patients treated obtained only short-term (< 6 weeks) relief of their symptoms, presumbly because of elastic recoil of the displaced tissues, and it became clear that the elasticity of the prostatic capsule or, more accurately, the anterior fibromuscular stroma had to be exhausted during dilatation to maintain the results. It also was appreciated that dilatation is most likely to be successful when the commissures of the prostate are disrupted. I2 The results of the present study appear to endorse this conclusion as do the endoscopic findings of Isorna and associates.l:’ Indeed, one group of pioneers of the techniciue were so impressed by the importance of this change that they refer to the method as “balloon divulsion of the prostate.“12
If stretching and tearing of the fibromuscular stroma and visible splitting of commissures are required, the ideal balloon would be one that can remain seated within the prostate and concentrate all its dilating forces there. Singlelength balloons tend to migrate out of the prostate into the bladder, in part because they extend across the bladder neck. It appears, based on this report and those of MarksI and of the bladGoldenberg et al., 6 that dilatation der neck is not required to achieve successful results. Moreover, such extension of the balloon reduces the force exerted against the fibromuscular stroma and prostatic capsule. Lack of concentration of dilating force within the prostate may partially explain the variability and short duration of some results achieved losing one-size-fits-all balloons, even when appropriate candidates have been treated. Two objections can be raised against BDI? The first is that, unlike transurethral resection. balloon dilatation yields no tissue for histologic examination. It is, therefore, imperative that the urologist evaluate the patient thoroughl\. losing the best available methods such as prosdigital rectal examinatate-specific antigen, tion, and transrectal ultrasound imaging with biopsy if indicated. If there is an!’ sllspicion of cancer, BDP is not appropriate. The second objection is that the olltcome, as assessed by uroflow measurements. is not alLvays striking. For example, although Weiss and associates’” found an early increase in peak flow rates, the change was not aluays statisticall) significant as the length of folloiv-lip increased.
However, their series was small, which confounds statistical analysis, and some of the changes were considerable. The 7 patients who were evaluated at one, three, and six months had an increase in peak uroflow from 8.5 mL/ set predilation to 13.1 mL/sec at three months, and still had an average rate of 12.1 mL/sec at six months-a decline that may not be significant, depending on the volume voided. In a study at Hammersmith Hospital, 42 percent of the patients felt that their urinary stream was moderately to greatly improved by BDP, whereas the remainder were equally divided between those who felt there was no change or a worsening.s However, this was an unselected population of patients. In his two-year followup of patients treated with BDP, Klein16 found that the peak flow rate had improved from pretreatment values in 13 patients at last study but had diminished in 7. What probably is clinically significant is that the symptomatic outcome of various treatments for BPH consistently correlates poorly with the changes in uroflow, and it is the symptomatic effects that are the goal. Although the first report of angioplasty was published in 1964, the technique attracted little enthusiasm in the United States until Gruntzig and Hopff17 introduced the double-lumen polyvinylchloride dilating balloon in 1974, after which transluminal angioplasty became a safe and practical option. Similarly, the devices for prostatic dilatation that were reported beginning in 1844 had various drawbacks that caused dilatation to be replaced by transurethral prostatectomy. The Agency for Health Care Policy and Research (AHCPR) is developing BPH treatment guidelines which segment appropriate treatments for patients with mild, moderate, or severe symptomatology. Balloon dilatation is one of the BPH treatment alternatives being included in these guidelines. The guidelines suggest that these patients be offered a range of treatment alternatives. Mildly symptomatic patients might benefit most from watchful waiting, and severely symptomatic patients are good candidates for prostate surgery. It is within the moderately symptomatic group where the BDP procedure may be most appro-
318
priate after patient and urologist consider the relative treatment outcomes. On the basis of this and other studies, BDP is not only an effective procedure but durable as well. Almost all patients who experience initial success should expect their result to endure for a minimum of twenty-four months. Properly executed dilatation with a sized-to-fit intra-prostatic balloon is a safe and effective alternative to conventional surgery for the treatment of symptomatic BPH in appropriately selected patients. 1901 4th Avenue,
San Diego,
Suite
California
A~:I
G. MOSELEY.
M.D.
From the Department of Urology, Harbor View Medical Center and Sharp Memorial Hospital, San Diego, California ABSTRACT-Seventy-seven patients with small prostates (200 mL ultrasonically determined using Bladder Scan (Diagnostic Ultrasound Corporation, Kirkland, Washington) or of prostate cancer. A total of 77 patients satisfied these criteria and gave informed consent to participation in the study. Their mean age was 64.4 years (range 45 to 95 years), and the average gland size as determined by transrectal ultrasound was 18.49 g (SD 5.76). Patients were evaluated pre-dilatation and at intervals thereafter by both subjective and objective measures. Their symptoms were rated by the Madsen-Iversen scale, with obstructive symptoms being scored a maximum
of 1X and irritative symptoms a maximum of 9. The peak urinary flow rate (PQ) and voided volume were measured using a Urolab 1152 (I,ife-Tech Instruments, Houston, Texas). The adjusted P.sures. bladder neck, and bladder. A lubricated calibration catheter was passed through the cystoscope bridge and positioned in the bladder under direct observation. The Foley balloon on the catheter was inflated and drawn back lightly against the bladder neck. catheter was maintained While the calibration at the vesical neck, the sheath and lens were withdrawn slowly while the operator observed the markings at l-cm intervals along the catheter shaft. The measurement at the distal aspect sphiwtm indicated the length of of tlw rxternul the prostatic urethra and appropriate size dilatation balloon. The calibration catheter was then withdrawn, the bladder was filled, and the sheath and lens were replaced with the introduction sheath and obturator provided with the dilatation balloon catheter. The dilatation catheter was then passed through the sheath into the bladder, and the terminal 15-n1L Foley balloon was inflated and pulled back against the bladder neck. The dilatation ‘balloon was positioned in the prostatic urethra and its position confirnled endoscopitally by observing the white marker band on the catiheter shaft distal and adjacent to the external sphincter. The balloon was inflated to 3 atm of pressllre (45 psi) and maintained for ten minrltes. The sized-to-fit intra-prostatic balloon did not migrate into the bladder, but locked within the prostate during inflation. After dilatation, the balloons were deflated and then withdrawn back into the sheath, protecting the urethra. and the sheath and catheter were removed. The treated area was examined endoscopically to confirm the presence of commissurotomy or divulsion through the fibromuscular stroma (Fig. 1). A Foley catheter was inserted after surgery to prevent urinarv retention from blood clots or edema. All patients were kept overnight on a twenty-three-hour stay and sent home the fol-
1. Anterior ~ornn~i,vsurotoIIl1( clnd tear through fihi-ornusmlar .stroina rfwlting jroin forces gcvwratcd hy .sized-to-jit intra-pmvtatit dilatation halloon. FI(:lJItE:
lowing day with instructions to remove the catheter forty-eight hours later. Cefazolin sodium (Ancef) 1 g was administered intravenously to all patients one hour prior to the operation and ever!’ eight hours postoperatively. Patients received ctephalexin 500 mg bid for five days after treatment. Patients were followed initially at on, with belladonna and opium 60 mg suppositol-irs. l’hcre \\.ere no significant complications and no cases of incontinence, impotencca, retrograde ejaculation. or lrrethral strictures.
AVERAGE PEAK UROFLOW
16
AVERAGE 16-
SYMPTOM
SCORE t
-cl-
OBS
-o--
IRR
-#TOTAL +/- S.E.M.
12$ 8 lo-
!
6-
ffl
6-
1
-.-
I
= MEAN +/- S.E.M.
1
/
I
I
I
0 PRE N ? ?77
I 3M0 N = 43
I 6M0 N : 44
/ 12 MO N=40
PRE n = 72
I 10 MO N : 20
3 MOS n = 57
24 MO N:ll
6 MOS n = 46
FOLLOW-UP
12 MOS n ? ?37
18 MOS n = 18
24 MOS n = 10
(Months)
3. Peak uroflow at various times after BDP Values at three, six, and twelve months are significantly differentfrom pretreatment values at p = 0.0001. Value at eighteen months is significant at p = 0.0225. The p value at twenty-four months (0.4331) is of que.stionable utility because of small number of patients. FIGURE
FOLLOW-UP
(Months)
FIGUHE 2. Average
obstructive (OBS), irritative (IRR), and total symptom scores after BDP Va1ue.s for obstructive, irritative, and total symptoms are significantly different from pretreatment values (p = 0.0001) at all follow-up times.
Of the 43 patients with symptom scores available at three months, 91 percent had obtained at least a 50 percent reduction in their overall score; the average decrease was 12.07 points (Fig. 2). In nearly all cases improvement was maintained over the total length of followup. The average total symptom score declined from 16.47 + 4.35 preoperatively to 4.36 f 3.28 (n = 44) at six months, 4.48 f 3.65 (n = 40) at twelve months, 3.90 f 2.02 (n = 20) at eighteen months, and 3.82 f 1.47 (n = 11) at twenty-four months. In most patients, obstructive symptoms tended to be more responsive than irritative ones, with mean reductions of 80 percent and 47 percent, respectively. In the entire series, the mean symptom score at last follow-up had declined by 70 percent (SD 19%), from 16.47 to 4.65. At last follow-up, 87 percent of patients experienced a 50 percent or greater reduction in symptom score. The uroflow data likewise reflected the utility of BDP At last follow-up, 49 percent of patients experienced a 50 percent or greater increase in PQ. At three months, the patients examined had an average PQ of 14.07 mL/sec vs 8.25 mL/sec preoperatively (Fig. 3). The improvement was maintained at subsequent time periods. The adjusted PQ in the entire series of
316
patients improved from an average of 0.77 + 0.37 pretreatment to 1.19 f 0.63 at three months. There was a slight decline at six months (1.10 k 0.53), after which the adjusted PQ stabilized at approximately 1.14 over the remainder of the study (data not shown). An indication of the natural history of postdilatation BPH can be gained from Table I, wherein is described patients who were seen for all scheduled follow-ups for the first year after dilatation. It is apparent that although most patients had fluctuations in their symptom score, in only 1 patient did the score at twelve months approach the pretreatment value. Initial symptom score reductions remained stable at eighteen and twenty-four months. Comment Early trials of BDP produced inconsistent results,3,4 but through years of clinical experience, balloon dilatation pioneers have retrospectively developed patient selection criteria. Although not all the criteria have been defined, an appropriate candidate for BDP appears to have a small prostate (< 40 g), confirmed obstructive symptomatology, adequate detrusor function, and primary lateral lobe hyperplasia.5 7 General contraindications include a large gland (>40 g), significant middle lobe hyperplasia,
lJHOI>O(;Y
// API200 mL, chronic urinary retention). untreated prostatitis, active urinary tract infection. severe untreated urethral strictures, and prostate cancer.8-g The most extensive clinical experience with balloon technology has been in the arterial system in percutaneous transluminal angioplast): Although it was believed initially that this technique worked by compressing plaque, Castaneda-Zuniga et al. lo pointed out in 1980 that such a mechanism was not plausible, given the nature of artherosclerotic material. In extensive experimental work since, they have shown that successful angioplasty requires stretching of and controlled damage to the outer layers of the arterial wall with fracture of the plaque.” Much the same concept appears to apply to prostatic balloon dilatation. Several of the first patients treated obtained only short-term (< 6 weeks) relief of their symptoms, presumbly because of elastic recoil of the displaced tissues, and it became clear that the elasticity of the prostatic capsule or, more accurately, the anterior fibromuscular stroma had to be exhausted during dilatation to maintain the results. It also was appreciated that dilatation is most likely to be successful when the commissures of the prostate are disrupted. I2 The results of the present study appear to endorse this conclusion as do the endoscopic findings of Isorna and associates.l:’ Indeed, one group of pioneers of the techniciue were so impressed by the importance of this change that they refer to the method as “balloon divulsion of the prostate.“12
If stretching and tearing of the fibromuscular stroma and visible splitting of commissures are required, the ideal balloon would be one that can remain seated within the prostate and concentrate all its dilating forces there. Singlelength balloons tend to migrate out of the prostate into the bladder, in part because they extend across the bladder neck. It appears, based on this report and those of MarksI and of the bladGoldenberg et al., 6 that dilatation der neck is not required to achieve successful results. Moreover, such extension of the balloon reduces the force exerted against the fibromuscular stroma and prostatic capsule. Lack of concentration of dilating force within the prostate may partially explain the variability and short duration of some results achieved losing one-size-fits-all balloons, even when appropriate candidates have been treated. Two objections can be raised against BDI? The first is that, unlike transurethral resection. balloon dilatation yields no tissue for histologic examination. It is, therefore, imperative that the urologist evaluate the patient thoroughl\. losing the best available methods such as prosdigital rectal examinatate-specific antigen, tion, and transrectal ultrasound imaging with biopsy if indicated. If there is an!’ sllspicion of cancer, BDP is not appropriate. The second objection is that the olltcome, as assessed by uroflow measurements. is not alLvays striking. For example, although Weiss and associates’” found an early increase in peak flow rates, the change was not aluays statisticall) significant as the length of folloiv-lip increased.
However, their series was small, which confounds statistical analysis, and some of the changes were considerable. The 7 patients who were evaluated at one, three, and six months had an increase in peak uroflow from 8.5 mL/ set predilation to 13.1 mL/sec at three months, and still had an average rate of 12.1 mL/sec at six months-a decline that may not be significant, depending on the volume voided. In a study at Hammersmith Hospital, 42 percent of the patients felt that their urinary stream was moderately to greatly improved by BDP, whereas the remainder were equally divided between those who felt there was no change or a worsening.s However, this was an unselected population of patients. In his two-year followup of patients treated with BDP, Klein16 found that the peak flow rate had improved from pretreatment values in 13 patients at last study but had diminished in 7. What probably is clinically significant is that the symptomatic outcome of various treatments for BPH consistently correlates poorly with the changes in uroflow, and it is the symptomatic effects that are the goal. Although the first report of angioplasty was published in 1964, the technique attracted little enthusiasm in the United States until Gruntzig and Hopff17 introduced the double-lumen polyvinylchloride dilating balloon in 1974, after which transluminal angioplasty became a safe and practical option. Similarly, the devices for prostatic dilatation that were reported beginning in 1844 had various drawbacks that caused dilatation to be replaced by transurethral prostatectomy. The Agency for Health Care Policy and Research (AHCPR) is developing BPH treatment guidelines which segment appropriate treatments for patients with mild, moderate, or severe symptomatology. Balloon dilatation is one of the BPH treatment alternatives being included in these guidelines. The guidelines suggest that these patients be offered a range of treatment alternatives. Mildly symptomatic patients might benefit most from watchful waiting, and severely symptomatic patients are good candidates for prostate surgery. It is within the moderately symptomatic group where the BDP procedure may be most appro-
318
priate after patient and urologist consider the relative treatment outcomes. On the basis of this and other studies, BDP is not only an effective procedure but durable as well. Almost all patients who experience initial success should expect their result to endure for a minimum of twenty-four months. Properly executed dilatation with a sized-to-fit intra-prostatic balloon is a safe and effective alternative to conventional surgery for the treatment of symptomatic BPH in appropriately selected patients. 1901 4th Avenue,
San Diego,
Suite
California
A~:I
