The paraffin-containing therapeutic Prostalong-Fizomed device in complex treatment of patients with chronic prostatitis.
Associate Member of the RussianAcademy of Medical Sciences, Prof. Yu. G. Alyaev; M. A. Gazimiev, D. M. S.; V. I. Rudenko, D. M. S.; T. A. Uzhegov, C.M.S.I.M.SechenovMoscowMedicalAcademy
Chronic prostatitis (CP) is still a very common, underexplored, and therapy-resistant disease. Information on CP epidemiology is limited and conflicting. Domestic researchers estimate its prevalence between 8% and 35% in men aged between 20 and 45 years. CP is diagnosed lately ever more frequently in older men, including its combination with prostatic adenoma.
Modern medicine does not possess reliable data pertinent to possible causes or mechanisms of development of CP. Both bacterial and abacterial forms of prostatitis are discerned. According to literature sources, the prevalence of chronic bacterial prostatitis ranges between 6% and 10%, and that of chronic abacterial prostatitis is 80-90%.
The major role in the treatment of bacterial prostatitis belongs to antimicrobial therapy. The frequent use of nonsteroidal anti-inflammatory drugs (NAID) in this patient category appears to be rather rational and pathogenetically substantiated. The rectal route of administration seems to be the most appropriate in this disease.
Russian publications have reiterated again and again that the use of enzymatic preparations is efficient and rational in the treatment of CP. Administration of gadrenoblockers is a novel approach in the treatment of chronic prostatitis. The optimal effect of the use of gadrenoblockers is currently believed to be achieved in patients with prostatitis whose urination function is impaired. Plant formulations have performed well in the treatment of this disease as well.
Russian urologists put numerous physiotherapeutic approaches to their use in the treatment of chronic prostatitis much more frequently, as compared to practitioners in other countries. However, pathogenetic rationale of this practice has not been sufficient, and further efficacy analysis is required.
Although there are plenty of therapeutic regimens and treatment modalities in the treatment of CP, many authors acknowledge that there are currently no substantiated enough approaches to the treatment of chronic prostatitis.
Choice of the most adequate and efficient treatment modality is therefore paramount, because this patient category needs time-consuming, multistage, systematic measures of therapy and rehabilitation. Considering that protracted pharmacotherapy presents an economic burden for the patient and health care, and often causes adverse reactions in various organs and systems, it is no wonder that practitioners show an interest in medical means whose application would not be accompanied by the risk of adverse effects or entail considerable expenses. This is just the reason why complex treatment of CP in this country involves the extensive use of natural physical factors, which potentially enhance the effects of medicines, ensure dose reduction or discontinuation of some drugs, and improve drainage and blood circulation in the prostate.
Based on the above, we considered a study of the clinical efficacy of the paraffin-containing therapeutic Prostalong-Fizomed device (PTD Prostalong-Fizomed ) warranted. The basic component of this device is medicinal paraffin that has undergone certain processing. The development of this appliance was based on a special technology applied to process ecologically pure medicinal paraffin, which, possessing direct effects on relevant receptor areas, without being heated as is the common practice, can activate microcirculation and metabolic and regenerative processes in the prostate.
The PTD Prostalong-Fizomed presents an elastic belt with a paraffin-containing element fixated over the lumbosacral spine.
Clinical observations and study methods
We evaluated 59 patients with chronic prostatitis aged between 29-56 years. Duration of disease was from 1 to 3.5 years. Concurrent diseases were diagnosed in 18 subjects: hemorrhoids in 12 of them, chronic cholecystitis in 4 subjects, osteochondrosis of the lumbar spine in 4 patients, and arterial hypertension in 2 patients. Nine subjects had chronic prostatitis combined with prostatic adenoma.
The diagnosis of chronic prostatitis was based on the patient’s complaints, digital rectal examination of the prostate, microscopic and bacteriological studies of prostatic secretion, transrectal ultrasonography, and Doppler sonography. Furthermore, all patients had uroflowmetry with residual urine volume measurement to allow urination efficacy assessment. Three patients underwent magnetic resonance imaging of the prostate.
Initial visit results demonstrated that all subjects had previously been treated for CP at various health centres: 35 of them (59.32%) had had temporary improvement and the other 24 (40.68%), minor improvement.
The most common complaint that had led patients to the clinic was pain. In 16 subjects (27.11 %), suprapubic pain was documented, 23 patients (38.98%) reported perineal pain, 8 patients (13.56%) complained of pain in the scrotum, and 12 subjects (20.33%) presented with inguinal pain. Aggravation of pain after sexual intercourse was reported by 16 patients (27.11%).
Dysuria (frequent, painful, constrained urination) of various severity was documented in 24 patients (40.67%).
Sexual disturbances (decreased libido, erectile dysfunction) were reported by 48 subjects (81.35%).
On digital rectal examination, 36 patients (61.01%) had a pastous, tender, and unhomogeneous prostate, with varying degrees of these abnormalities.
On ultrasonic examination, moderately increased prostate volumes were observed in 27 patients (45.76%) and diffusely increased echogenicity of the prostate parenchyma, in 14 subjects (23.72%).
Nine patients (15.25%) had microorganisms in the prostatic secretion found on bacteriological examination: E. coli, Mycoplasma, Ureaplasma. Microscopic evaluations of prostatic secretion revealed excessive amounts of leukocytes in all patients (over 10-14 hpf).
To allow objective assessment of the efficacy of the PTD Prostalong-Fizomed , we assigned subjects to three clinically identical groups at baseline. Group 1 subjects (20 individuals) were administered a 20-day course of antibacterial (doxycycline 100 mg twice a day for 10 days and josamycin 500 mg twice a day for 10 days) and anti-inflammatory therapy (diclofenac 50 mg in suppositories). Group 2 patients (20 individuals) received a 3-month course of monotherapy with the PTD Prostalong-Fizomed . Group 3 was comprised of 19 patients who had combined treatment: a 20-day course of antibacterial and anti-inflammatory therapy (with the same drugs as in Group 1) and a 3-month therapeutic course with the PTD Prostalong-Fizomed .
Efficacies of the administered treatment regimens were assessed using data of follow-up evaluations and control instrumental tests (analysis of patients’ complaints, testing prostatic secretion, uroflowmetry, and prostate ultrasonography). Subjects were monitored over a period of 3 months. The safety and tolerability of the administered therapeutic regimen were evaluated considering documented adverse effects.
Considering the different duration of treatment in the study groups, the final evaluation of treatment efficacy was carried out immediately upon discontinuation of treatment. In Group 1 – after the 20-day course of antibacterial and anti-inflammatory therapy and the follow-up bacteriological evaluation of prostatic secretion conducted three weeks later. In Groups 2 and 3 – three months later. Data of comparative analysis of treatment results in the study groups are shown in Table 1.
In Group 1, significantly reduced severity of pain or its complete elimination were documented in 16 patients (80%). Enhanced sexual function (improved libido) was reported by 12 subjects (60%). In 2 of 6 patients who had had urination disorders before treatment, no such disturbances were present anymore at follow-up.
On prostate palpation, the procedure was painless in 13 patients (65%), but the prostate was still pastous and moderately tender in 7 subjects (35%). No more microflora growth was detected on follow-up (three weeks after treatment) bacteriological tests of prostatic secretion.
Follow-up microscopy of prostatic secretion revealed decreased hpf leukocyte counts that had returned into the normal range in 16 patients (80%).
In Group 1 patients administered antibacterial and anti-inflammatory therapy, three subjects had adverse reactions, such as nausea and epigastric pain, without the need to discontinue the treatment.
Results of continuous follow-up in Group 2 demonstrated that monotherapy with the PTD Prostalong-Fizomed was associated with no adverse reactions in any patient. Practically, all 20 patients reported subjective improvement.
Reduced severity of pain during and after sexual intercourse was reported by 17 patients (85%). In 11 subjects
(55%), there was no more pain; 14 other patients (70%) reported enhanced sexual function (more intensive libido and improved erection). In 3 of 6 patients who had had urination disorders before treatment, no such disturbances were present anymore at follow-up.
On prostate palpation, positive changes were observed in the majority of the patients. In 14 patients (70%), the prostate was painless on digital examination. On follow-up bacteriological tests of prostatic secretion, pathogenic microflora was again detected with the pattern being identical to that observed before treatment.
Follow-up microscopic investigation of prostatic secretion revealed decreased hpf leukocyte counts that had returned into the normal range in 15 patients (75%).
On follow-up ultrasonography, statistically significant reductions in the prostate volume were observed in 17 patients (85%).
Of special interest is one fact that requires further investigation and analysis. Namely, the disappearance of previously observed hyperechoic inclusions in the prostate parenchyma in 4 out of 5 patients. Only one patient still had a hyperechoic area in the prostate, but it was smaller as compared to the pre-treatment finding.
Subjectively, all patients reported feeling better after the therapeutic Prostalong-Fizomed course and noted the convenience of the device and the quality of the material used in the production of it, which has implications for prolonged and continuous use.
In Group 3, significantly reduced severity of pain or its elimination were documented in 17 patients (89.5%). Eleven subjects (57.9%) reported complete elimination of the pain. Enhanced sexual function (more intensive libido and improved erection) was reported by 13 subjects (68.42%). In 4 of 6 patients who had had urination disorders before treatment, no such disturbances were present anymore at follow-up.
On prostate palpation, positive changes were observed in the majority of the patients. In 14 patients (74.7%), the prostate was painless on digital examination. On follow-up bacteriological tests of prostatic secretion, pathogenic microflora was again detected with the pattern being identical to that observed before treatment. Follow-up microscopic investigation of prostatic secretion revealed decreased hpf leukocyte counts that had returned into the normal range in 18 patients (94.7%). Two patients developed adverse effects, nausea and diarrhea, which did not necessitate discontinuation of the treatment.
The novel paraffin-containing therapeutic Prostalong-Fizomed device is a safe and efficient means applicable in the treatment of patients with chronic prostatitis. This treatment resulted in better general condition of patients (both on subjective and objective assessments) and considerable improvement in or elimination of the majority of symptoms of chronic prostatitis. The ease of use and good tolerability allow to recommend this device for prolonged use in patients with chronic prostatitis, either as monotherapy or in combination with antibacterial and anti-inflammatory therapy.