PROSPECTIVE RANDOMIZED COMPARISON OF HIGH ENERGY TRANSURETHRAL MICROWAVE THERMOTHERAPY VERSUS alpha-BLOCKER TREATMENT OF PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA

PROSPECTIVE RANDOMIZED COMPARISON OF HIGH ENERGY TRANSURETHRAL MICROWAVE T H E R M O T H E W Y VERSUS (YBLOCKER TREATMENT OF PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA BOB DJAVAN, CLAUS G. ROEHRBORN, SHAHROKH SHARIAT, KEYWAN GHAWIDEL MICHAEL MARBERGER

LVLI

From tlie Department of Urology. Uniuersity of Vierma, Vienna, Austria, and tlie Department of Urology, The Unrversit? of Texas Southioestern Medical Center. Dallas. Texas

ABSTRACT

Purpose: We compare directly the efficacy and safety of targeted high energy transurethral microwave thermotherapy with a-blocker treatment for benign prostatic hyperplasia (BPH). Materials and Methods: In this randomized prospective study 52 patients with symptomatic BPH received terazosin and 5 1 underwent high energy transurethral microwave therapy with topical anesthesia. Patient evaluation included determination of International Prostate Symptom Score (I-PSS), peak flow rate and quality of life score before transurethral microwave therapy or terazosin and periodically up to 6 months thereafter. Results: At 2-week followup the terazosin group transiently exhibited significantly greater improvement than the transurethral microwave therapy group in mean values of all 3 primary efficacy parameters of I-PSS, peak flow rate and quality of life score. At 12 weeks and 6 months this pattern was reversed, and the transurethral microwave therapy group achieved significantly greater improvement than the terazosin group in mean I-PSS, peak flow rate and quality of life score. By 6 months 78.4, 64.7 and 84.3% of the transurethral microwave therapy group demonstrated a 50% or greater improvement in I-PSS, peak flow rate and quality of life score, respectively, compared with 32.7, 9.6 and 40.4% of the terazosin group, respectively. Nine patients in the terazosin group and 1 in the transurethral microwave therapy group withdrew from study because of side effects or lack of treatment efficacy. Conclusions: Terazosin afforded more rapid improvement in symptoms, voiding function and quality of life in BPH patients. High energy transurethral microwave therapy offered markedly superior clinical outcomes a t 12 weeks to 6 months. KEY WORDS:microwaves; adrenergic alpha receptor blockaders; hyperthermia, induced; prostatic hypertrophy

Among the prominent strategies for medical management ative incidence of adverse events. The primary study end of benign prostatic hyperplasia (BPH) is blockade of points were changes in the International Prostate Symptom a-adrenergic receptors with agents, such as terazosin, de- Score (I-PSS) and peak flow rate. signed to relax prostatic smooth muscle.'-:l Thermoablation of obstructive prostatic tissue is the chief aim of several MATERIALS AND METHODS minimally invasive procedures, including transurethral miA total of 103 patients with moderate to severe BPH sympcrowave thermotherapy. In sham controlled clinical trials of toms were enrolled in this study a t the University of Vienna. transurethral microwave therapy improvements of 40 to 70% Study entry criteria are summarized in table 1. All patients in symptom score and 14 t o 609 in peak urinary flow rate gave informed written consent and were randomized in a 1:1 have been documented,"-' and significant improvements in ratio to receive terazosin (52)or undergo high energy transquality of life scores have been reported.i', i 2 Recent evidence urethral microwave therapy (51). The method of randomizaindicates that transurethral microwave therapy can be pertion alternated the group assignments of consecutive paformed using topical urethral anesthesia alone with some tients one by one. Before treatment a history was taken and microwave treatment systems.'" physical examination was performed. Pretreatment evaluaFew data have been reported directly comparing the safety tion also included transrectal ultrasound imaging, serum and efficacy of n-blockers to transurethral microwave thera- prostate specific antigen (PSA)determination and uroflowmpy.14 The chief hypothesis tested by our study was whether etry. I-PSS was determined by a self-administered questionhigh energy transurethral microwave therapy versus terazo- naire, which included a question for determining quality of sin would afford superior outcomes in BPH patients. We life score by the World Health Organization method. Foldetermine the magnitudes of posttreatment changes in lowup evaluations of I-PSS, peak flow rate and quality of life symptoms, urinary flow rates and quality of life scores at score were conducted during clinic visits at 2,6 and 12 weeks, various times up to 6 months as well as assess the compar- and 6 months after the start of terazosin treatment or transurethral microwave therapy. Accepted for publication July 28, 1998. Patients in the terazosin group received 1mg. terazosin daily Editor's Note: This article is the first of 5 published in this for 3 days followed by 2 mg. daily for 1 week and 5 mg. daily for issue for which category 1 CME credits can be earned. In- 2 weeks. Subsequently in patients who did not achieve a 35% structions for obtaining credits are given with the questions or greater improvement in I-PSScompared with the preon pages 286 and 287. 139

MICROWAVE THERMOTHERAPY VERSUS a-BLOCKER TREATMENT

140

TABLE1. Study entry criteria

-_ Inclusion Criteria

Exclusion Criteria

____

-_

wBlocker treatment aithln preceding 3 months Prior finasteride use. prostate surgey or other prostate procedure Post-void residual greater than 250 ml. Neurogenic bladder Acute urinary retention Prostate Ca Prostatitis Bladder Ca Prostate volume greater than 100 cm.:’ _ _ _ _~~

I-PSS 9 or greater Peak flow rate less than 12 mlJsec. with voided vol. 150 ml. or greater Age 4 5 4 5 yrs. Prostatic urethra length 3&50 mm.*

Determined by transrectal ultrasound.

treatment value the terazosin dose was increased to 10 mg. daily. Terazosin was continued throughout t h e remainder of the 6-month followup. The Targis* microwave system was used to administer targeted high energy transurethral microwave therapy. After induction of topical urethral anesthesia with 2%lidocaine gel microwave power was applied in increments until a target urethral temperature of 40 ? 1C was reached. Thereafter microwave power was applied continuously for 1 hour. After treatment all patients who underwent transurethral microwave therapy were catheterized for 24 hours, at which time they returned to the clinic for a voiding trial. Catheter usage was continued in patients unable to void after 24 hours and they were reevaluated for ability to void 1 and 2 weeks after treatment. Data were analyzed using statistical software. Mean values of I-PSS, peak flow rate and quality of life, and corresponding 95% confidence intervals (CI) were calculated. Within and between group differences were evaluated by repeat measures analysis of variance or Student’s t test. Comparisons were made on a 2-tailed basis. The study design afforded statistical power of 92% to detect a between group mean I-PSS difference of 2 with a common within group standard deviation of 3. Differences in percentages of patients achieving various cumulative improvement deciles with last available data carried forward to 6 months were assessed by Mann-Whitney U test. Actuarial treatment failure rates were evaluated by the Kaplan-Meier method. The significance of between group difference in failure rates was determined by log rank test. A multivariate logistic regression model was constructed with patients classified as responders if they achieved a 35%or greater I-PSS improvement versus baseline at followup.3 Based on a recent study a t t h e University of Vienna13 involving the same patient selection criteria it was anticipated that a 35% or greater I-PSS improvement would correspond to a 5 point or greater absolute decline in symptom score in all patients. On average patients perceive a 5-point symptom decline as a moderate improvement in BPH symptom^.'^ The study statistical power w a s 95% to detect a n absolute 30%-between group difference in the proportion of patients achieving a 35%or greater I-PSS improvement.

* Urologix, Inc., Minneapolis, Minnesota.

RESULTS

None of the pretreatment parameters differed significantly between the 2 groups (table 2). Mean values of pretreatment and posttreatment I-PSS, peak flow rate and quality of life score are summarized in table 3. Symptoms. In the transurethral microwave therapy group 54.9 and 45.1%of patients had moderate (9 or less I-PSS)and severe (20 or greater I-PSS)pretreatment symptoms, respectively, which was not significantly different compared with 63.5 and 36.5%in the terazosin group, respectively ( p = 0.38). Symptoms improved promptly aRer treatment in both groups (fig. 1) and improvements by 6 months were statistically significant ( p <0.0005). Maximal improvement with terazosin was observed by 6 weeks and thereafter symptoms remained stable. By contrast, I-PSScontinued to decline progressively in the transurethral microwave therapy group throughout t h e 6-month observation. At 2 weeks mean I-PSS i n t h e terazosin group (14.0, 95% CI 13.2 to 14.8) was 11.4% lower ( p = 0.01) t h a n in the transurethral microwave therapy group (15.8,95%CI 14.7 to 16.9, fig. 1).However, from 12 weeks through 6 months in the transurethral microwave therapy group mean I-PSS was significantly lower ( p <0.0005) than i n the terazosin group (fig. 1). By 6 months mean I-PSS in the transurethral microwave therapy group ( 6 . 8 , 9 5 8 CI 6.2 t o 7.5) was 38.2%lower than i n t h e terazosin group (11.0,95% CI 10.2 to 11.9).At 6 months various cumulative deciles of symptom improvement in the transurethral microwave therapy group were significantly higher ( p <0.0005) than i n the terazosin group. For instance, by 6 months 78.4%of t h e transurethral microwave therapy group experienced a 50% or greater improvement in I-PSS compared with 32.7%of t h e terazosin group. Absolute I-PSS improvements of 3 or 4 or greater (100.0%)at t h e last followup were significantly larger ( p = 0.013 a n d p = 0.007, respectively) in the transurethral microwave therapy group than in the terazosin group (88.5 and 86.5%, respectively). Pretreatment age, prostate volume, transition zone volume, PSA, I-PSS, peak flow rate and quality of life score were evaluated for entry into a multivariate logistic regression model. Type of treatment (terazosin or transurethral microwave therapy) was also evaluated. The only variables significantly predictive of response to treatment were pretreatment I-PSS ( p = 0.0191) and type of treatment ( p = 0.0013).

TABLE2. Pretreatment patient data Terazosin

Parameter

p Value

Mean

Age Prostate vol. (cm.3) Transition zone vol. (cm.3) PSA (nglml.)

I-PSS

Peak flow rate ( m l l s e c . ~ Quality of life score

Transurethral Microwave

64.0 39.1 18.0 2.2 18.9 8.9 38

(954CI) (60.9-67.1) 136.541.7) (16.9-19.1) (1.8-2.6) (18.0-19.9) (8.4-9.3) (3.5-4.0)

Mean

66.2 39.6 18.0 2.8 19.4 8.3 3.9

(954CI) (64.0-68.4) (35.643.7) (15.6-20.4) (2.3-3.3) (18.5-20.3) (7.9-8.8) (3.74.2)

0.25 0.83 0.98 0.06 0.46 0.10 0.29

~

~

141

MICROWAVE THERMOTHERAPY VERSUS u-BLOCKER TREATMENT

TABLE3 . Pretreatment and posttreatment efficacy pararneters ___ ___ Transurethral Microwave Therapy

Terazosin

-f Terazosin

aTUMT ** p < 0.0005

Value*

~~

6 Mos.

Baseline

-~

Baseline

6 Mos.

~~~

-___

51

I-PSS:

#

Mean 18.9 11.0 19.4 6.8 9.5%CI 18.0-19.9 10.2-11.9 18.5-20.3 6.2-7.5 p Value? <0.0005 <0.0005 Peak flow rate I rnl./sec. ): hlean 8.9 11.6 8.3 13.9 9 5 1 C1 8.4-9.3 11.2-12.1 7.9-8.8 13.2-14.6 p Value? <0.0005 <0.0005 Quality of life score: Mean 3.8 2.1 3.9 1.3 95qi CI 3.5-4.0 1.9-2.4 3.7-4.2 1.0-1.5 p Value: <0.0005 10.0005 I Between group comparison from 12 weeks to 6 months. f Within group comparison between baseline and 6 months.

#

h

.;0.0005

0

a,,

3

l12 4I

<0.0005

U

a

<0.0005

1

50

6

2

0

6

12

26

Time (wk)

+Terazosin

FIG.2. Mean peak flow rate in terazosin and transurethral microwave therapy (TUMT)groups. Numbers above or below data points indicate number of observations at each respective data point. Error bars display 959 CI. For between group comparisons p values are at indicated time points before treatment and during followup. Qrnax, peak flow rate. wk, week.

TUMT

rn

20

-

15

-

51

v)

a

49

10

-

I

c JI

**

* p =0.01 ** p < 0.0005

** "

J

0

43

2

6

12

I

I

26

Time (wk) FIG.1. Mean I-PSS in terazosin and transurethral microwave therapy (TUM?1 groups before treatment and during followup. Numbers above or below data points indicate number of observations at each respective data point. Error bars display 95% CI. For between group comparisons p values are at indicated time points. urk,week.

Patients who underwent transurethral microwave therapy were significantly more likely to respond to treatment than those who received terazosin (odds ratio 30.7, 95% CI 3.8 to 247.4). Higher pretreatment I-PSS was also associated with greater probability of treatment response (odds ratio 1.28, 9 5 9 CI 1.04 t o 1.57). Peak flow. Peak flow rate increased at 2 weeks in the terazosin group, reaching a plateau by 6 weeks (fig. 2). At 2 weeks peak flow rate decreased in the transurethral microwave therapy group but increased thereafter continuously throughout followup. The increases in peak flow rate by 6 months compared with baseline were statistically significant in both groups ( p <0.0005).Mean peak flow rate at 2 weeks in the terazosin group (10.9 ml. per second, 9 5 9 CI 10.4 to 11.3)was 41.69 higher ( p <0.0005) than in the transurethral microwave therapy group (7.7 ml. per second, 95% CI 7.1 to 8.2).However, from 12 weeks through 6 months mean peak flow rate was significantly higher (p <0.0005) in the transurethral microwave therapy group. At 6 months mean peak flow rate in the transurethral microwave therapy group (13.9 ml. per second, 95% CI 13.2 to 14.6) was 19.8%greater than in the terazosin group (11.6 ml. per second, 95% CI 11.2 to 12.1). Significantly greater percentages of patients in the transurethral microwave therapy group compared with the terazosin group (p <0.0005)demonstrated various cumulative deciles of Deak flow rate improvement, including a 5 0 8 or greater incrkase in 64.7%in the transurethral microwave

therapy group versus 9.6%in the terazosin group. At the last followup the percentages of patients with absolute peak flow rate improvements of 3 ml. per second or greater (86.3%) or 4 ml. per second or greater (72.54)in the transurethral microwave therapy group were significantly higher (p <0.0005)than in the terazosin group (36.5 and 11.5%,respectively). Quality oflrfe. In both groups mean quality of life score declined promptly (fig. 3), reaching significantly lower levels by 6 months (p <0.0005). At 2 weeks mean quality of life score was 2.8 ( 9 5 9 CI 2.5 to 3.1) in the terazosin group compared with 3.2 (95%CI 3.0 to 3.5) in the transurethral microwave therapy group (p = 0.033). In contrast, from 12 weeks to 6 months mean quality of life was significantly lower in the transurethral microwave therapy group ( p <0.0005), declining a t 6 months (1.3, 95% CI 1.0 to 1.5) 38.1%lower than in the terazosin group (2.1, 9 5 9 CI 1.9 to 2.4). Significantly greater percentages in the transurethral microwave therapy versus terazosin group ( p <0.0005) achieved various cumulative deciles of quality of life score improvement. Thus, by 6 months 84.3%in the transurethral

+Terazosin 51

4-

3-

2 -

*

p=o.m

0

2

6

12

26

Time (wk) FIG.3. Mean quality of life (QOL)in terazosin and transurethral microwave therapy (TUMT) groups. Numbers above or below data points indicate number of observations at each respective data point. Error bars display 9 5 9 CI. For between group comparisons values are at indicated time points before treatment and during ~ U O W U P . wk., week.

142

MICROWAVE THERMOTHERAPY VERSUS a-BLOCKER TREATMENT

microwave therapy group demonstrated a 50% or greater improvement in quality of life score compared with 40.4%in t h e terazosin group. Treatment failure. Patients were judged to have treatment failure if they withdrew from study because of unsatisfactory treatment efficacy or adverse events (side effects or complications 1. A total of 10 patients withdrew from the study due to side effects ( 6 in the terazosin group) or lack of treatment efficacy ( 3 in the terazosin and 1 in the transurethral microwave therapy group). The actuarial rate of treatment failure a t 6 months in the terazosin group was 17.3% (95% CI 9.0 t o 31.0) compared with 2.0ct ( 9 5 7 CI 0.0 to 13.0) in the transurethral microwave therapy group ( p = 0.0085). Adtvrse etvnts. There were 17 adverse events in the terazosin group and 7 in the transurethral microwave therapy group (table 4 ) . The most commonly adverse events in the terazosin group were dizziness, asthenia and headache. Three urinary tract infections in the transurethral microwave therapy group were treated with antibiotics and no cases of persistent bacteriuria were noted. Of 51 patients in the transurethral microwave therapy group 46 (90.2%1 were able to dispense with the catheters after 24 hours. Catheterization was needed in 4 patients (7.8%) and 1 ( 2 % )in the transurethral microwave therapy group for 1 and 2 weeks, respectively. No patient who underwent transurethral microwave therapy required catheterization for more than 2 weeks. DISCUSSION

Terazosin proved to be more rapid in onset of action than transurethral microwave therapy with maximal effects reached by 6 weeks. In contrast, improvement in the transurethral microwave therapy group continued through t h e 6-month followup. Recently reported evidence indicates that the maximal effects of high energy transurethral microwave therapy manifest themselves by 6 months.lz The limitations of terazosin treatment included lack of effectiveness is 5.8% of patients and side effects prompting discontinuation in 11.5%. Adverse events necessitating treatment discontinuation have recently been reported in 13.3 to 20.4%of terazosin recipients.l.:L 16 17 Targeted high energy transurethral microwave therapy proved by 12 weeks and thereafter to be markedly more efficacious than a-blockade by a broad range of measures. The actuarial treatment failure rate i n the terazosin group a t 6 months in our study ( 17.3%)was comparable in magnitude to that a t 1 year in a large scale multicenter clinical trial (11.2%).:$Notably, however, 6 of the 10 treatment failures were due to adverse events in the terazosin group, and the types of adverse events were different from those in the transurethral microwave therapy group. Furthermore, while patients in the terazosin group had the option to discontinue treatment because of side effects, those who underwent

TABLE4. Adverse events

transurethral microwave therapy were not able to terminate the effects of treatment. Terazosin treatment resulted in a 42% mean symptom improvement by the end of our study, a value in close accord with the 38 to 45% improvement reported in previous studies.',:'. 18.19 Like our study these reports indicated t h a t maximal or near maximal symptomatic relief i s attained a s early a s 6 weeks with terazosin. Thus, it appears unlikely that the between group differences in symptom improvement in our study could have been attributable in substantial part to inadequate terazosin dose titration. A multivariate logistic regression model revealed a significantly higher probability of treatment response with high energy transurethral microwave therapy than terazosin. Pretreatment I-PSS was the only pretreatment variable found to be a significant predictor of treatment response in the terazosin and transurethral microwave therapy groups. In contrast, pretreatment I-PSS was recently found not to be predictive of treatment response in patients undergoing transurethral prostatectomy.20 Certain limitations of our study should be recognized. The duration of followup was 6 months, and whether t h e observed differences between the terazosin and transurethral microwave therapy groups will endure during a longer period remains to be determined. Only 1 a-blocker was evaluated. The study design did not include a placebo or sham arm, nor was there a placebo lead-in period. Thus, the study did not afford a n opportunity to evaluate the contribution of nonspecific effects (that is placebo or sham effects). Perceived differences in intensiveness of treatment or extent of patient involvement between terazosin and transurethral microwave therapy could lead to differing nonspecific effects in accord with cognitive dissonance theory. However, marked differences in nonspecific effects have not been apparent in previous studies. Thus, previous terazosin clinical trials have demonstrated significant improvements of 16 to 18% in mean symptom score and 8 to 13%'in mean peak flow rate in the placebo arms;2.3 while in transurethral microwave therapy clinical trials patients undergoing a sham procedure experienced improvements of 10 to 36% in mean symptom score and -9 to 26% in mean peak flow rate.4-7.9-11 Furthermore, improvements in mean symptom score and mean peak flow rate with terazosin and transurethral microwave therapy have generally exceeded those of placebo and sham procedure, respectively, by 2 to 7-f0ld.~-~."-11In our study the magnitude of treatment related effects was substantially greater t h a n t h a t of placebo and sham related effects reported previously. CONCLUSIONS

Terazosin treatment led to rapid improvement in symptoms, voiding function and quality of life in BPH patients and provides a suitable option for those requiring rapid relief of the condition or preferring medical management to procedural intervention. High energy transurethral microwave therapy yielded markedly superior clinical outcomes by 6 months and may be considered in patients when the major priority is long-term improvement.

No Adverse Events Terazosin

Dizziness ksthenia Headache Hypotension Nausea Postural dizziness Urinary tract infection Epididymitis Hemospermia Loss of ejaculate Urinary retention greater than 1 wk.

7

0

4 3 1 1 1

0

0 0 0

3 1 1 1

0

1-

0

-

~

Transurethral Microwave Therapy

0 0 0

0

REFERENCES

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