British Journalof Urology (1992), 70, 178-182

01992 British Journal of Urology

Localised Deep Microwave Hyperthermia in the Treatment of Benign Prostatic Hyperplasia: Long-term Assessment A. YERUSHALMI, D. SINGER, R. KATSNELSON, E. LEVY and A. SHANI Department of Cell Biology, Weizmann Institute of Science; Clinical Hyperthermia Unit, Department of Urology and OncologicalInstitute, Kaplan Hospital, Reho vot, Israel

Summary-A group of 133 patients with benign prostatic hyperplasia who were either poor operative risks or who had refused surgery underwent localised deep microwave hyperthermia, without supplementary drugs. In 59% of patients who had had an indwelling catheter, freedom from urological obstruction and satisfactory voiding were maintained for 7 years and catheterisation was not required. In patients with severe prostatic symptoms, 65% showed general improvement and satisfactory voiding for 8 years. There were no side effects. Patients who relapsed were given a second course of treatment and 75% responded positively. This positive response and the lack of side effects suggest that localised deep microwave hyperthermia may be an effective alternative to surgery in the management of high risk patients and those who are reluctant to undergo surgery.

Benign prostatic hyperplasia (BPH) is the commonest neoplastic disease in man. The increase in prostatic volume and the morphological incidence of BPH with age are well established (Franks, 1954). There is no effective conservative management and the only effective treatment is either transurethral or open prostatectomy, but in many cases this is contraindicated by the patient’s advanced age and/or other diseases (Walsh, 1979; De Klerk, 1983). These considerations led us to develop the technique of localised deep microwave hyperthermia, thus permitting non-surgical treatment of BPH without side effects. Local hyperthermia (LH), combined with radiotherapy or chemotherapy, has been used for the last 3 decades in the treatment of a variety of tumours in man (Corry et al., 1980; Noel1 et al., 1980; Engelhardt, 1987). To date, most data on hyperthermia as treatment for cancer relate to patients at an advanced stage of the disease, allowing only short-term follow-up. No information on the longterm response has been available. Accepted for publication 27 January 1992

In 1980 we began to treat BPH with LH. Since neither sedation nor anaesthesia was required, it was possible to treat patients on an out-patient basis. The first clinical results were reported by Yerushalmi et al. (1985) and our techniques and protocol have been adopted by others (Servadio et al., 1986; Lindner et al., 1987, 1990). Treatment of BPH with LH has also taken the form of transurethral hyperthermia (Astrahan et al., 1989). In the last 3 years LH has been used more often for the treatment of BPH and its efficacy has been firmly established (Baert et al., 1990; Lindner et al., 1990; Strohmaier et al., 1990; Wada et al., 1990; Zerbib et al., 1990). We report our experience in the treatment of BPH with local hyperthermia over a period of 10 years.

Patients and Methods The study was carried out on 133 patients; 89 had severe prostatic symptoms and 44 had either bladder outflow obstruction or > 150 ml residual urine requiring an indwelling catheter for 1 to 10

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months prior to treatment. During this period, up to 4 attempts to dispense with catheterisation had failed. Patients with urethral strictures were excluded from the study. Prostatectomy was indicated in all cases, but patients either refused or were unable to undergo surgery because of other diseases. Local hyperthermia was proposed as an alternative to surgery. The method of treatment, protocol and the limitations of the clinical trial were explained to each patient and they were included after giving written consent. Before and after treatment, patients were assessed by routine urological investigations, i.e. imaging (IVU or ultrasound), physical examination (including digital palpation of the prostate), biochemistry (neural function tests, urine analysis and culture) and other tests (measurement of residual urine and flow rates, cystoscopy and prostate biopsy). Since the study covered a 10-year period, it should be noted that ultrasound and accurate flow measurements were implemented during this time and not all patients were diagnosed by these techniques. Symptom analysis was based on the patient's account of the quality of the urinary stream, hesitancy, urgency, nocturia and frequency. A symptom score system (Table 1) was designed to assess the benefit of treatment (Jensen et al., 1983). The total obstructive symptom score was calculated by combining the individual scores. The therapeutic gain ratio of treatment was the ratio of the post-treatment to the pre-treatment total score. Clinical status was graded as 3 for a ratio of over 50% post-treatment to pre-treatment total score, 2 for a ratio of 30 to 50% and 1 for a ratio of less than 30%. Standardised forms for data collection and analysis formed the basis of the evaluation. At follow-up the same evaluation was repeated at monthly intervals for the first 3 months and at 6monthly intervals thereafter. Treatment Localised hyperthermia, at 42.5 to 43"C, was delivered by a transrectal applicator operating at

2.45 Ghz. The applicator was equipped with a cooling system to avoid overheating of the rectal mucosa and rectal wall, which were maintained at 32°C or lower (Yerushalmi etal., 1985; Yerushalmi, 1986, 1988).The temperature of the prostatic mass could not be measured non-invasively and so invasive temperature measurements were not performed routinely. The intratumour temperature was evaluated by an algorithm based on accumulated temperature measurements confirmed by invasive temperature measurements (Yerushalmi et al., 1985).The algorithm's validity was confirmed by invasive temperature measurements (Wada et al., 1990). Hyperthermia treatments were given twice weekly in 12 to 16 sessions, each lasting 1 h on an out-patient basis, without sedation, anaesthesia or supplementary drugs.

Results The treatment was well tolerated by all patients and there were no acute or long-term side effects, no damage to the rectal mucosa or rectum and no irritative voiding symptoms. For evaluation purposes the patients were divided into 2 groups. Group 1 comprised 89 patients without a catheter whose severe prostatic symptoms were treated with local hyperthermia; 82 were assessed (Table 2) using the assessment and symptom scoring system previously described. According to the symptom score, 80% of these patients benefited from a single treatment. Objectively, peak flow rates increased by an average of 27% (from 8.2 to 10.4 ml/s), with an average mean flow rate increase of 23% (from 4.2 to 5.2 ml/s). Residual urine measurements after treatment were < 100 ml (average 67) compared with a pre-treatment average of 86 ml. There was no significant change in prostate size as determined by digital palpation and ultrasound. In 65% of patients the improvement persisted for 8 years. The condition of 13% of patients who

Table 1 Symptom Score Scale Scale

Frequency

0 1 2

Normal voiding 0 Mild frequency ( x 2-3/h) x1 Moderate frequency ( x 1.5-2/ x 2-3 h) Severe frequency ( x l/h) x 4-5 Very severe ( x 15-30/min) >5

3 4

Nocturia

Quality of urinary stream

Urgency

Hesitancy

Good Satisfactory Weak

None Mild Mild

None Mild Mild

Poor

Severe

Severe

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treatment. After treatment, 66% of these patients were able to dispense with their catheter and had spontaneous micturition, with residual urine

Localised deep microwave hyperthermia in the treatment of benign prostatic hyperplasia: long-term assessment.

A group of 133 patients with benign prostatic hyperplasia who were either poor operative risks or who had refused surgery underwent localised deep mic...
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