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   제목   Summary of BPH Published Papers
   작성자   관리자     작성일   2016-02-03
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2. SUMMARY OF PRIOR CLINICAL RESULTS IN PUBLISHED PAPERS

Background
One of the prevalent disorders in men over 50 years old is enlargement of the prostate gland.  In medical 
terms, this is known as benign prostatic hyperplasia (BPH).  The main known cause of BPH is primarily related 
to aging. The male population above the age of 60 has a high probability for developing BPH. This disorder 
causes discomfort and difficulties in voiding urine and requires removal of prostate tissue or chronic drug 
treatment.  Historically, transurethral resection of the prostate (TURP) using electric energy has been used 
[1].

Based on a concept presented in Figure 1, a high intensity focused ultrasound (HIFU) device called the 
Sonablate 200 has been developed [2].  The device has undergone clinical testing in several countries [3,4] 
and based on demonstrations of safety and efficacy, this device has received approval for routine clinical 
use in Japan through the Ministry of Health and Welfare.  In Europe the device meets regulatory requirements, 
such as, TUV, CE, and GS Mark. 

Summaries of Published Clinical Papers
Long term clinical results from two previous studies at Indiana University School of Medicine [3] and the 
University of Vienna [4] show some of the presumptive safety and effectiveness data.  These two studies 
reported an overall improvement of uroflow of about 50 % and a 53% decrease of urinary symptoms one year 
after treatment. Based on the most recent clinical studies with an indwelling catheter left in place during 
treatment, an improvement of over 40% in peak uroflow and significant decline in symptom scores from 21 to 7 
have been observed.

In June 1992, an international clinical trail was initiated to evaluate the safety and efficacy of 
transrectal HIFU for patients with symptomatic BPH. In this non-randomized phase-II clinical trial, 
approximately 250 BPH patients were treated worldwide with the Sonablate transrectal device and several 
institutions have published the results [3,4,6]:

Bihrle et al. [3] reported their experience with 15 patients and a follow up for 90 days.  The maximum flow 
rates increased from 9.3 ml/sec. to 14.0 ml/sec and the post-void residual urine volume decreased from 154 ml 
to 123 ml.[Table 1]

                        TABLE 1 POST - HIFU (SONABLATE) TREATMENT RESULTS

							                3 Months
				      Pre-Tx  (n)	                Post-Tx (n)
     Peak Flow Rate (ml/sec) 	       9.3    (15)                       14.0   (15)	

     AUA Symptom Score		       31.2   (15)                       15.8  (15)
 
     Post-Void Residual (ml)	       154    (15)                        123  (15)


 Madersbacher [4] reported on an initial series of 50 patients, 20 of whom were followed for 12 months.  The 
maximum urinary flow rates (QMax , ml/sec.) increased from 8.9 ± 4.1, to 12.4 ± 5.6 at 6 months (n=33), and 
to 13.1 ± 6.5 at 12 months (n=20).  In the same time period, the post volume residual volume (ml.) decreased 
from 131 ± 83 to 59 ± 42 (6 months) and down to 35 ± 30 (12 months).  The American Urological Assessment 
(AUA) Symptom Score declined from 24.5 ± 4.7 to 13.3 ± 4.4 (6 months) and 10.8 ± 2.5 (12 months) [Figure 2]. 
The authors observed a 47% improvement of uroflow and a 53% decrease in urinary symptoms 1 year after 
treatment [Table 2]. In principle, these data confirm a recent update reported by Foster et al. [5] of 86 
patients treated at Maderbacher’s institution [Figure 3].

                           TABLE 2 POST - HIFU (SONABLATE) TREATMENT RESULTS 

					                     6 Months	                12 Months
				 Pre-Tx  (n)                Post-Tx  (n)                 Post-Tx  (n)
    Peak Flow Rate (ml/sec.)	  8.9    (50)                12.4    (33)	          13.1    (20)

    AUA Symptom Score             24.5   (50)                13.4    (33)                 10.8    (20)


 Ebert et al. [6] treated 35 patients, 8 of whom were in urinary retention. The maximum flow rate increased 
from 7.6ml/sec. to 15.2 ml/sec.  Within the same time period, the post void residual volume decreased from 
182ml. to 50ml., and the IPSS (International Prostate Symptom Score) from 17.9 to 7.1 [Figure 4].

Overall, HIFU treatment was well tolerated. Rectoscopy done immediately after the procedure yielded normal 
results in all patients [4,7].  The predominant side effect observed in almost all patients was urinary 
retention.  Therefore, Madersbacher[7] routinely placed a #10 French cytostomy catheter intraoperatively, 
which was removed on an outpatient basis after a mean of 6 days.  The majority of sexually active patients 
reported hematospermia, which disappeared spontaneously after 4-6 weeks [3,4,7]. Madersbacher et al. [7] 
results are shown in Table 3.

TABLE 3. POST - HIFU (SONABLATE) TREATMENT RESULTS

  
							   6 Months	          12 Months
					Pre-Tx  (n)        Post-Tx  (n)          Post-Tx  (n)**
       Peak Flow Rate (ml/sec.)		 6.4     (30)         12.8     (30)	  13.5     (30)

       IP Symptom Score (IPSS)		 17.8    (30)	      6.3      (30)        9.4     (30)

       Post-Void Residual (ml)		  205    (30)          38      (30)         60     (30)

**  Estimated from Figure in Paper

Sanghvi et al. [8], in 1996, reported a comparison of 15 patients treated with a protocol that did not 
include ablation of the area of the bladder neck and 7 patients with such ablation.  Of the 15 patients, 59 % 
were judged to be treated effectively. Their peak flow rates went from 9.2 to 13.9 ml/sec.  Whereas, those 
patients who received ablation including the bladder neck had improved flow rates form 9.8 to 17.3ml/sec 
[Figure 5].

A published study by Nakamura [9], in 1996, also showed improved results of the revised procedure.  Response 
after 3 months was good to excellent in 90% of the patients treated with HIFU. On average, QMax (maximum 
urinary flow rate) went up from 6.5 ml/sec. to 13.2 ml/sec., while IPPS improved by more than 95% [Figure 
6].  These improvements are very close to meeting the response rate seen in TURP procedures while providing 
the added advantage of noninvasive surgery.  The main post treatment side effect observed was urinary 
retention for three to four days post treatment. All complications were resolved without incident [Table 4].  

Two clinical papers published in 1997 showed recent experience in Japan and Canada when patients received 
therapy that included ablation at or near the bladder neck:

 Uchida and Koshiba [10] reported 92.7% of 14 cases were treated effectively.  Flow rates increased from 8.2 
to 15.0 ml/sec. at 6 months post treatment (p<0.05). Average IPSS was significantly improved (p<0.0001).  
Urinary retention was noted in 43% of patients that lasted from 2 to 21 days. No other adverse complications 
were observed.
 Sullivan et al. [11] of the Vancouver Hospital and Health Sciences Centre reported results on 25 patients. 
Average AUA symptom score went from 20.25 to 9.56.  Flow rates increased from 9.2 to 13.7 ml/sec. And quality 
of life scores improved from 4.75 to 2.50. Complications included 6 patients with transient hematospermia, 10 
with urinary retention and 2 with hematuria. All complications resolved without incident.
 


 CONCLUSIONS

In addition to BPH relief, HIFU has provided other clinical benefits, such as, minimal use of anesthesisa, 
reduced bleeding, reduced morbidity, and reduced hospital stay [3,4].  Overall HIFU treatment was well 
tolerated.  With respect to complications of therapy, summary journal articles by Foster et al. (1994) [12] 
and Madersbacher and Marberger (1996) [13] report that the majority of patients experienced transient 
hematuria that disappeared after 90 days. No patients reported a change in erectile or sexual function 90 
days after treatment.  Postoperative dysuria and uretheral discomfort was almost absent [Figure 7]. Table 5 
shows a compilation from 6 papers in which post treatment complications were given.  There are 174 patients 
in total.  Since there could have been differences in patient selection criteria and complication reporting 
among the authors, this compilation of data may not be totally justifiable. In the report of US clinical 
trials in a later section, complication rate data from controlled studies are presented    All authors 
reported that cited complications were resolved without further difficulties.

                          TABLE 5. REPORTED COMPLICATIONS

	Transient Urinary Retention			125/174	(72%)  
	Transient Hematospermia			         67/174	(38%) 
	Transient Microhematuria			 24/174	(14%) 
	Transient Macrohematuria			 20/174	(11%) 

	Urinary Tract Infection			         7/174	( 4%) 
	Epididymitis					 3/174	( 2%)
	Retrograde Ejaculation			         1/174	(<1%)
	Perineal Hematoma				 1/174	(<1%)
	Dysuria					            0	( 0%)
	Erectile Dysfunction				    0	( 0%)
	Urethral Strictures				    0	( 0%)
	Incontinence				  	    0	( 0%)
	Anal Discomfort			  	            0	( 0%)
        Rectal Lesions			 		    0	( 0%)

 



  REFERENCED PARERS

1.Mebust, W. K., Holtgrewe, H. L., Cockett A. T. K., et al.; Transurethral Prostatectomy; Immediate and 
Postoperative Complications, J. Urology 141; 243-247, 1989.

2.Sanghvi, N. T., Foster, R. S., Fry, F.J., Bihrle, R., Hennige, C, Hennige, L.; Ultrasound Intracavitary 
System for Imaging, Therapy, and Treatment of Focal Disease; IEEE Ultrasound Symp. Pros., Cat. No. 
92CH3118-7; 1249-1253, 1992.

3.Bihrle, R., Foster, R. S., Sanghvi, N. T., Donohue, J. P., Hood, P.J.; High Intensity Focused Ultrasound 
for the Treatment of BPH; Early U. S. Clinical Experience; J. Urology, Vol. 151; 1271-1275, 1994.

4.Madersbacher, S., Kratzik, C., Susani, M., Marberger, M.; Tissue Ablation in Benign Prostatic Hyperplasia 
with High Intensity Focused Ultrasound; J. Urology, Vol. 152; 1956-1961, 1994.

5.Foster, R. S., Bihrle, R., Sanghvi, N. T., and Donohue, J. P.; High Intensity Focused Ultrasound for the 
Treatment of BPH; Seminars in Urology, Vol. XII, no.3; 200-204, August 1994.

6.Ebert, T., Sadler, D., Miller, S., Schmitz-Drager, B., and Ackerman, R.; High Intensity Focused Ultrasound 
in the Treatment of Benign Hypertrophy of the Prostate; Urologe [A], 34; 404-408, 1995.

7.Madersbacher, S., Klinger, C. H., Schatzl, G., Schmidbaur, C. P., and Marberger, M.; The Impact of 
Transrectal High Intensity Focused Ultrasound on Prostatic Obstruction in BPH Assessed by Pressure Flow 
Studies; EUR. UROL. 30, 437-445, 1996.

8.Sanghvi, N. T., Fry, F. J., Bihrle, R., Foster, R. S., Phillips, A.V., Zaitsev, A. V., and Hennige, C.W.; 
Noninvasive Surgery of Prostate Tissue by High-Intensity Focused Ultrasound; IEEE Transactions on 
Ultrasonics, Ferroelectronics, and Frequency Control, Vol. 43, November 1996.

9.Nakamura, K.; Treatment of BPH (Benign Prostatic Hypertrophy); High-Intensity Focused Ultrasound (HIFU); 
Current Therapy, Vol. 43, no.11; 119-125, 1996.

10.Uchida, T. and Koshiba, K.; High-Intensity Focused Ultrasound (HIFU) for Treating Benign Prostatic 
Hyperplasia; Japanese Journal of Endourology and ESWL, Vol.10, no.1; 20-22, 1997.

11.Sullivan, L. D., McLoughlin, M. G., Goldenburg, L. G. Gleave, M. E., and Marich, K. W.; Early Experience 
with High-Intensity Focused Ultrasound for the Treatment of Benign Prostatic Hypertrophy; British Journal of 
Urology, 79; 172-176, 1997.

12.Foster, R. S., Bihrle, R., Sanghvi, N. T., and Donohue, J. P.; High Intensity Focused Ultrasound for the 
Treatment of BPH, Seminars in Urology, Vol. XII, no. 3 (August); 200-204, 1994.

13.Madersbacher, S., and Marberger, M.; High Intensity Ultrasound in Urology, Japanese Journal of Endourology 
and ESWL, Vol. 9, no. 1, 1996.
 
14.Sanghvi NT Fry FJ, Bihrle R, Foster RS, Phillips MH, Syrus J, Hennige C. Non-invasive surgery of prostate 
tissue by high intensity focused ultrasound, IEEE Trans. Ultrasonics, Ferro el. Freq Control 1996;43:1099-
1110.

15.Uchida T., Muramoto M., Kyunou H. Clinical outcome of high intensity focused ultrasound for treating 
benign prostatic hyperplasia: preliminary report, Urology 1998; 52:66-71.

16.Sanghvi NT, Foster RS, Bihrle R, Casey R, Uchida T, Phillips MH, Syru J, Zaitsev AV, Marich KW and Fry FJ. 
Clinical Paper: Noninvasive surgery of prostate tissue by high intesity focused ultrasound: an updated 
report, Europ. J. of Ultrasound 9, 1999 19-29.




     
 
         

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