PROTOCOL OF Medical Tests of the BIOFON Urogenital Apparatus for IR-Therapy

1. TEST GROUNDS

Extract from Protocol No.4 of 10.10.97 by committee on Modern Medical Technologies under Russian Federation Ministry of Health.

2. SITE AND TIME OF TESTING

2.1. Moscow Regional Research Clinical Institute after M.F.Vladimirsky, Department of Deprmatovenerology & Dermatooncology, 61/2, Ul. Schepkina, Moscow.

2.2. Start of the tests: February 20, 1998

End of the test: May 6, 1998

3. BRIEF DESCRIPTION OF THE APPARATUS

3.1. The BIOFON Urogenital Apparatus for IR-therapy is designed for physiotherapy of uroprostatitis of chlamydia and postchlamydia etiology.

3.2. The apparatus is intended for use in clinics and out-patient departments.

3.3. The apparatus is powered by 2.8-3.2V internal source (two 1.5V elements of Energizer type).

3.4. Power consumption is more than 0.1A.

3.5. Apparatus weight: 0.3kg.

3.6. Overall dimensions: 156x82x30mm.

3.7. The apparatus contains a source of infrared radiation with a wavelength range of 0.8-30 Ојm.

3.8. IR-radiation power: 0.1-1.0mW.

3.9. Treatment session duration: 24± 1 s.

3.10. IR-radiation is generated during first 12± 1 s.

3.11. Distance to the patient: 0.05-0.5m.

3.12. The apparatus provides control and indication of the following parameters on a built in charactor indicator:

- session duration

- number of sessions performed

- power supply discharge

3.13. The apparatus provides light indication of device switching on, procedure start and finish, radiation mode finish, as well as sound signaling of procedure start and finish.

3.14. Operation mode time setting after apparatus switching on does not exceed 1s.

4. MEDICAL TESTING PROCEDURE

Medical trials with the BIOFON urogenital apparatus for IR-therapy were carried out in a from of a complex therapy of the patients with chronic complicated urogenital chlamydiosis using immunotherapy ("VIFERON" suppositories, 500 000 units twice a day, for 30 days), enzymotherapy (Chemotripsin, 10mg intramuscular, N10), topical treatment (urethra instillation using 2% Protargol solution, baths with 2% Protargol solution, prostate massaging, Vashkevich tamponade, processing of the sperm tubercle with 10% solution of argentum nitrate), antibiotic therapy according to a reduced scheme (by Claritromycin, 250mg by mouth, twice a day, for 10 days). Treatment by the BIOFON apparatus has been carried on as described in "Operating Manual ЕИФЮ. 941 527.001Р Р­ for the BIOFON apparatus for IR-therapy" for 1 month. A testing programme is presented in Appendix 1.

The BIOFON apparatus was installed on the table at the patients breast level at a distance of 0.5m. Follow-up patents underwent a complex clinical and laboratory examination. To diagnose chlamydia infection srapes obtained from urethra mucus membrane and cervical canal have been studied using direct immunoflurescence method (DIF) with 'Clamonosreen' monoclonal antibioties (Niarmedic Co.). This method has been also used to determine ureaplasma and mycoplasma infection of urethra and cervical canal. To exclude gonococcal, trichomonadial or gardnerella infection of urogenital organs staining of smears taken from urethra, cervical canal of the uterus and vagina has been performed by a blue and according to Gram. Topical diagnostics of the pathological process in the urogenital organs has been made by: urethroscopy; palpation of the prostatic gland and sperm tubercles, as well as examination of their scretion; bimanual examination in women, two-glass urine test in men; complete blood counts, urinalysis, biochemical analysis of blood (functional liver samples, blood sugar).

5. CHARACTERISTICS OF THE PATIENTS

In the course of BIOFON apparatus clinical tests 42 (27 males and 15 females) patients suffering from chronic urogenital chlamydiosis has been treated. Averge ages were 32.4 for men and 28.5 for women. The history of the disease varied from 6 months to 22 years (4.3 years in average). Among the patients there were 12 married couples, 10 unmarried men and 8 unmarried women.

In the past 26 patient underwent unsuccessful treatment for urogenital chlamydiosis, 16 of them were given more than 2 courses of antibiotics.

Clinical signs of chronic complicated urogenital chlamydia infection were revealed in all the patients (see Table I). The men complained mostly of itching and burning in urethra, pains in the perineum irradiating to the inguen, lumbus, scrotum and glaus penis, and mucopurulent discharges from the urethra. Five male patients had no subjective complaints, but urethra labial edema, labial redness and sticking, as well as increased leukocytosis in the urethra smears and prostate secretion were clearly marked. All 25 men were determine to have chronic total chamydia urethritis (in 19 of them there were signs of mild urethra infiltrate, in 6 of a transient infiltrate; in 25 patients symptoms of littritis and in 15 patients that of morganitis were found), chronic chlamydia prostatitis (in 10 patient - catarrhal, in 8 - follicular, in 7 - parenchimal), accompanied by colliculitis in every ease.

Women complained of burning, itching and pain in external genital organ area and anus, pains in the small pelvis, uresic disorders, vaginal discharges. Five women did not complain of anything.

Table I

6. MEDICAL TEST RESULTS

Clinical and laboratory curability control was undertaken in a month after finishing the course of treatment. Check up examination revealed no chlamydia infection in 33 (78%) patients (20 men and 13 women). In 9 patients the treatment was unsuccessful. Four men and two women continued to complain of burning and itching in the urethra, pains in the perineum, scare discharges from the genital organs. All the nine patients were administered ten-day-course of antibiotic treatment (Claritrormycin, 250mg by mouth, twice a day). As a result, clinical and etiological recovery occurred in all 9 patient (in a month after the end of treatment scrapes obtained from urethra and cervical canal of the uterus and examined by DIF-method revealed no chlamydia).

Table 2

CLINICAL EVALUATION OF THE BIOFON APPARATUS EFFEICIENCY

7. CONCLUSION

The BIOFON apparatus for IR-therapy is effective in complex treatment of patients with chronic complicated urogenital chlamydiosis in men and women.

In the course of clinical trials etiological recovery has been found to occur in 33(78%) of the patients with chronical complicated urogenital chlamydiosis due to the complex BIOFON apparatus application in combination with immunotherapy, enzymotherapy, topical treatment and antibiotic therapy by claritromycin with a reduced dose (250 mg by mouth, twice a day, for 10 days).

Indications for apparatus application are chronical chlamydiosis, complicated by chronic prostatitis in men or salpingo-oopphoritis in women. Contraindications has not been found. BIOFON is a compact, easy to use device for patients and personnel. Small number of procedures (1-2 a week), given during a month is also one of the advantages of this apparatus. Besides, short duration of a treating session, noninvasive way of treatment, absence of contraindications, ability to treat several patients during a single procedure may also be referred to the advantages of the device. It has been also observed that in case of failure of the method applied no resistance of chlamydia bacteria to the repeated courses of claritromycin therapy occurs.

8. RECOMMENDATIONS BASED ON THE TEST FINDINGS

The BIOFON Urogenital apparatus for IR-therapy is an effective tool in a complex (in combination with immunotherapy, enzymotherapy, topical treatment, antibiotic therapy (a reduce scheme )) treatment of chronic complicated urogenital chlamydia infection in men and women in clinics and out-patient environment.

M501 BIOFON apparatus for IR-therapy may be recommend for serial production and application in medical practice for complex treatment of chronic complicated urogenital chlamydiosis in men and women.