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UDC 616.65-007.61-089
TACTICS OF THE MANAGEMENT OF PATIENTS WITH BENIGN HYPERPLASIA OF PROSTATIC GLAND BY ITS LARGE VOLUME
Altai State Medical University, Barnaul
A.I. Neimark, B.A. Neimark, D.V. Torbik, D.D. Arzamastsev
There has been elaborated a differentiated approach to the management of patients with benign hyperplasia of prostatic gland (BHPG) by its large volume. The basis for the creation of algorithm were the results of long-term observations of 116 patients who were exposed to a particular minimally invasive surgery. there was performed a comparison of the effectiveness of removal of the infravesicular obstruction by means of bipolar transurethral resection of the prostatic gland (TURP), arterial embolization of the prostatic gland (EPA) and their combination. For the evaluation of the effectiveness of a particular method of treatment in control periods of time there were evaluated the following parameters: overall estimation of symptoms by prostatic gland diseases (IPSS), evaluation of the quality of life QoL, volume of the prostate and hyperplasia node according to the data of transrectal ultrasonography (TRUS) of the prostatic gland (PG), maximum urine flow rate (Q max). On the basis of the investigations there was proved the effectiveness of each method, and the minimal number of complications by comparable clinical effect was reached in the group, where endovascular intervention and transurethral resection were combined.
Key words: benign hyperplasia of prostate, arterial embolization of the prostatic gland, bipolar transurethral resection of the prostatic gland
Introduction. Benign hyperplasia of prostatic gland (BHPG) refers to the chronic diseases of urogenital system dramatically reducing the quality of patients' life [1, 2].
According to statistics, 30% of patients with BHPG at the age from 30 to 80 years require surgical treatment [3]. Due to the achievements of modern drug therapy the symptoms of the disease are being weakened for a long time, while the cause is not eliminated and the decompensation of the disease occurs already in the old age, when the concomitant pathology becomes the burden of the doctor and patient. According to the researchers, from 30,3% to 70-85% of patients which are planned for the operation has two or three concomitants diseases and more [4, 5]. The classical methods of BHPG treatment by ineffective conservative disease management are open adenomectomy - 27,2% of operations, and transurethral prostatic resection - 27,8% of operations.
Open adenomectomy by all its advantages concerning the radicality of treatment is characterized by high injury rate and risk of perioperative complications, thus, it does not suit for the treatment of somatically preoccupied patients. TURP is a more sparing procedure, but has implication restrictions. According to generally accepted recommendations, the volume of PG should range from 30 to 80 sm3 [6, 7]. The need for gradation of patients according to the prostate volume appeared on the verge of active introduction of transurethral prostatic resection. As it is known, the first models of resectoscope represented monopolar units using glucose solution for irrigation, and, consequently, there occurred the risk of TUR syndrome development.
This complication is determined by hemodilution having occurred in the systemic blood flow through perforated venous vessels with irrigation fluid. The risk of TUR syndrome developments increased proportionally to the growth of surgery time. The operation was considered safe by the duration of no more than one hour, the skills of surgeon at that stage allowed to perform prostate resection of no bigger than 60-80 sm3 in volume. The stated value had been settled in the urological literature for a long time as the border line between endoscopy and open surgery [8, 9, 10, 11].
During the last few years the improvement of medical hardware challenges the earlier established postulates. The method of plasma kinetic bipolar TURP used in the current research is characterized by a more effective hemostasis which allows to remove a bigger amount of prostate tissue per unit time. All this is possible due to the formation of plasma crown phenomenon around the resectoscope cutting loop in the SuperPulse regime. The energy charged ions inside the plasma crown cause the rupture of carbon-carbon and carbon-azotic bonds, and also leads to the dissociation of water molecules into active H+ and OH- ions. Hemostasis is performed on the level of capillary bed [12]. The implementation of this technology allowed to perform resection by the gland volume under 160 sm3 without considerable growth of risk of TURP typical complications.
However, there exists a group of patients for whom even such sparing method is heavy, in some cases endoscopic intervention is impossible - hip joint ankyloses, state after penile prosthesis with hard prosthetic devices.
From the beginning of XXI century in BHPG treatment there has been formed a fundamentally
different approach to the elimination of the problem. Initially, endovascular embolization of prostate vessels in urology was considered only as the means of control of urinary bladder and prostatic gland bleeding [13]. Having observed the reduction of prostatic gland volume by the improvement of the volume rate of urine flow in a number of patients, the researchers added the method to the armory. After several experiments on animal which proved the effectiveness and safety of EPA, preservation of fertility [14, 15, 16], the experiments on people were not long in coming.
The data on EPA effectiveness were presented in 2010 by Portuguese scientists headed by J.M. Pisco [17], national researchers (Neimark A.I., Karpenko A. A., Yakovets Ya.V.) [18]. In 2012 one more group of researchers headed by Carnevale F.C. mentioned an extremely high effectiveness of the method [19]. Every year there appear new researches devoted to the use of EPA by BHPG, and it is quite explainable - the advantages of endovascular interventions are: minimal invasion, low operation risk, quick recovery of patients, lack of necessity of anaesthetic support, possibility of implementation in elderly patients and in patients with heavy somatic pathology.
Research objective: to study and compare the effectiveness of minimally invasive operational techniques in treatment of patients with BHPG of large volume. To elaborate the algorithm of management of patient with large volume BHPG depending on the individual peculiarities.
Materials and methods
The work is based on the analysis of data of treatment of 116 petients with BHPG of large volume (over 80 sm3) according to the TRUS of prostate, which had been exposed to minimally invasive operations. The research period: September 2012 - January 2017.
The patients were divided into three groups:
First group (TUR), 44 patients: the group of somatically healthy patients by concomitant diseases (degree of anaesthetic risk according to ASA - I, II), which had been exposed to TURP.
Second group (EPA), 39 patients: patients having concomitant pathology by which the risk of TURP by large adenomas grew considerably (degree of anaesthetic risk according to ASA - III, IV). Such patients had been exposed to superselective embolization of prostatic gland arteries.
Third group (EPA+TRP), 33 patients: patients willing to obtain the effect of operative treatment as quick as possible, the somatic status of which was preoccupied, but allowed to perform TURP by the condition of prostate volume reduction to
80 sm3 (degree of anaesthetic risk according to ASA - II, III). TURP was performed in the first or third month after EPA depending on the degree of prostate volume reduction. A more long-term expectant period is unreasonable, as, according to our observations, the gland volumes decreases most rapidly during the period up to the third month of observation.
The average age of patients constituted 65,9 ± 8,65 years. This criterion and other main controlled parameters did not show statistically significant differences among the groups in the beginning of treatment.
Presurgical and control examinations were carried on the basis of the urological department of the multiprofile hospital of JSC Russian Railways at the Barnaul station.
Before inclusion into the group there was made general clinical examination. It included:
• complaints and history taking, physical examination
1. registration of patient's complaints,
2. filling in International Prostatic Symptom Score (IPSS), quality of life (QoL) questionnaires, detailed medical history taking - duration and character of the earlier conducted conservative therapy,
3. evaluation of the concomitant somatic pathology,
4. physical examination, digital rectal examination
• laboratory examination:
1. clinical blood analysis, clotting time, duration of bleeding.
2. common urine analysis,
3. syphilis blood test (RW), hepatitis B and C blood test - HBsAg, a - HCV.
4. determination of blood group and rhesus factor
5. biochemical blood analysis: total bilirubin, glucose, urea, creatinine, K+, Na+, prothrombin, fibrinogen, total protein, prothrombin index,
6. analysis of PSA total.
• instrumental methods of diagnosis:
1. electrocardiography,
2. fluorography,
3. USI of kidneys and urinary bladder with determination of residual urine,
4. TRUS of prostate,
5. urofluometry,
6. angiography of lesser pelvis vessels in patients planned for EPA.
• Additional investigations:
1. examination by therapist or, if necessary, other adjacent specialists on the basis of analysis results,
2. by high PSA total or suspicion of malignant process according to USI and digital rectal
examination data there was performed biopsy of prostatic gland out of 12 points.
TURP was conducted on the basis of the urological department of the multiprofile hospital of JSC Russian Railways at the Barnaul station according to Barnes method. There was implied the equipment of «Carl Storz» and «Olympus» firms, the diameters of resectoscope tubuses constituted 26 and 27 according to French scale respectively. The source of energy for TUR was the plasma-kinetic generator PK™ SuperPuls of GYRUS ACMI company.
Treatment by the method of embolization of prostatic gland arteries was carried on the basis of the department of X-ray operating methods of examination and treatment of Regional State Budgetary Institution of Healthcare "Regional clinical hospital" and on the basis of the department of radiology of multiprofile hospital of JSC Russian Railways at the Barnaul station. Endovascular interventions were conducted using angiographic complex Innova 4100 IQ GENERAL ELECTRIC (USA). Algorithm of EPA: puncture of the femoral artery according to Seldinger, insertion of the introducer into the lumen of femoral artery, then insertion of the guidewire and catheter of the appropriate configuration. Catheter is put behind the bifurcation of aorta to the internal iliac artery opposite to the point of puncture, after the visualization of the inferior vesical artery (Figure 1) into the catheter lumen there is introduced a microcatheter on its own guidewire (Figure 2) and there are introduced emboli till the effect of "stop contrast" (Figure 3).
Then the catheter and introducer are removed, and there is applied a compressing hemostatic bandage for 24 hours, the patients stays down for 24 hours. The procedure of intervention involved the catheters Roberts (Cook) with 5 F diameter and also the catheter elaborated exactly for the embolization of uterine arteries UFE-Type-1 AUB (Artery Uterine Bobrov) produced by Terumo (Japan). For the reduction of symptoms of post-embolization syndrome NSAIDS were administered during 5 days after EPA.
The work involved various methods of statistical data processing depending on the type of random values and the stated research objective.
For the evaluation of normalcy of distribution of characteristics there were used the excess kurtosis and skewness coefficients characterizing the form of distribution curve. The distribution was considered normal by the values of these coefficients from -2 to 2.
The values of continuous quantity are presented in the form of M ± m, where M - sample mean and m - standard error of mean. The values of qualitative characteristics are presented in the form of observed frequencies and percent.
In case of normal distribution and also equality of sample variance for the comparison of means the was used Student t-test. The equality of sample variance was evaluated according to F-criterion. For the comparison of linked samples there was implied paired Student t-test.
In case of distributions not corresponding to the normal one and also by inequality of dispersions there were used non-parametric Mann-Whitney U test (for independent samples) and Wilcoxon t-test (for linked samples).
For the comparison of qualitative characteristics there was used non-parametric x2 criterion. By the occurrence of minor frequencies (less than 10) for the stated criterion there was used Yates' correction. By the frequencies less than 5 there was implied Fisher's exact test. The critical level of statistical significance by the check of null hypothesis was set equal to 0,05. By the comparison of several groups Bonferroni correction for multiple testing was introduced.
The data processing was carried by means of programs Statistica 6.0, Excel 2007.
Results and discussion
The results of EPA treatment are presented in Table 1. The volume of prostatic gland, as the volume of hyperplasia node, reduced more significantly during the 1st and 3rd months of observation, the reduction was being registered till the 6th month, then the process became stable. Finally, by the 24th month of observations the prostate volume decreased by 40,82% of the initial one, the volume of palpable abnormality reduced by 44,0%. The volume of residual urine reduced rapidly by the 1st month after the carried EPA, in the further periods of observation there were no statistically significant changes registered. Such coefficient as Q max grew continuously up to the 12th month of observation, the inversely related values of IPSS and QoL, respectively, decreased in the same manner.
The PSA total level reduced significantly till the 3rd month of observation (period of most significant reduction of prostate and palpable abnormality level), then its level became stable up to the 24th month.
No serious complications by and after EPA (EPA group and EPA+TUR group) were registered. One case in early postsurgical period required troacar cystostomy due to acute urine retention.
In EPA+TUR group the averageprostate volume initially constituted 124,0±6,5 sm3. In TUR group it constituted 117,2±3,1 sm3. However, after the EPA by the moment of TURP performance the average volume of prostatic gland reduced significantly (P<0,001) and constituted 73,3±3,0 cm3, which was already reaching the standard of endoscopic intervention.
Figure 1.
Distal end of the angiographic catheter (1) is installed in the entrance of inferior vesical artery, its branches are contrasted - 2
Figure 2.
Microcatheter - 2 is put through the angiographic catheter - 1, prostatic arteries on the right are contrasted - 3
Figure 3.
EPA is performed on both sides, 1 - distal end of the angiographic catheter,
microcatheter is removed, there is observed the effect "stop contrast" in the projection of prostatic rterial bed
Figure 4a.
Ureteroscopic picture of the prostatic urethra of patient BHPG of large volume after EPA (1,5 th month after the procedure). There is registered the lack of contact hemophilia of the submucous membrane of prostatic urethra
Figure 45.
prostatic part of urethra of patient without prior EPA
BHPG of large volume
Low degree of anaesthetic risk
TURP by standart method
Reduction of PG with preservation of IVO by the 3rd month
Degree of anaesthetic risk higher than II according to ASA scale
I ~~~
EPA
Reduction of PG, elimination of IVO
Dynamic observation
Trial of recurrent EPA
HoLEP/other minimally invasive methods
Palliative cystostomy
Figure 5.
Scheme of management of patient with BHPG of large volume by means of minimally invasive operation techniques
Table 1
Results of EPA treatment (EPA group) - results of the measurement significantly differ from the values of the previous observations (P<0,05).
Observation period Before EPA 1st month 3rd month 6th month 12th month 24th month
PG volume (sm3) 134,0±8,3 100,1±7,2 P<0,001* 88,6±6,8 P<0,001* 81,6±6,7 P<0,001* 79,5±6,6 P=0,011* 79,3±6,6 P=0,968
PG node volume (sm3) 90,7±7,9 68,1±6,7 P<0,001* 58,6±6,5 P<0,001* 54,5±6,0 P<0,001* 52,1±6,2 P=0,052 50,8±6,3 P=0,417
Residual blood volume, ml 55,9±5,3 22,0±1,8 P<0,001* 20,4±1,7 P=0,658 19,4+1,7 P=0,818 15,5±2,1 P=0,212 16,2±2,2 P=0,943
Qmax (ml/s) 9,2±0,3 11,7±0,2 P<0,001* 14,9±0,4 P<0,001* 16,4±0,4 P<0,001* 15,4±0,5 P=0,004* 15,7±0,4 P=0,529
IPSS scores 28,2±0,7 18,4±0,7 P<0,001* 13,7±0,8 P<0,001* 11,5±0,7 P<0,001* 9,3±0,8 P<0,001* 9,7±0,8 P=0,152
QoL scores 4,8±0,2 3,1±0,2 p<o,ooi* 2,6±0,1 P=0,006* 2,4±0,2 P=0,019* 2,1±0,2 P=0,053 1,8±0,2 P=0,003*
PSA total (ng/ml) 5,9*1,1 3,5±0,8 p<o,ooi* 2,1±0,3 P=0,029* 2,0±0,2 P=0,740 2,1±0,2 P=0,491 2,6±0,2 P=0,057
Table 2
Comparative characteristics of minimally invasive treatment methods. Final period of observation - for EPA group - 12th month of observation, for TUR and EPA+TUR groups -
6 th month after TURP
Evaluated parameter Before treatment Final stage of observation
PG volume (sm3) EPA group 134,0±8,3 (pEBM™=0,729, p™=0,069) 79,3±6,6 (p™<<0,001 p^HOOl)
EPA+TUR group 124,0±6,5 (P^=0,729, PTLR=0,524) 21,3+0,7 (PFPA<0,001, P™=0,754)
TUR group 117,2+3,1 ^=0,069, Pepavi™=0,524) 22,4±0,8 0^0,001, pEPA™=o/754)
Residual blood volume, ml EPA group 55,9*5,3 (pEPA+TyFt0,022, p™=0,079) 16,2±2,2 ^^=0,935, p™=0,212)
EPA+TUR group 85,4+9,6 (Pkpa=0,022, P,u<=0,914) 14,7±1,9 (Pepa<0,935, Pul<=0,469)
TUR group 78,1±8,2 (Pepa=0,079, Pepa™=0/914) 11,7±1,3 (Pepa=0,212, PEPAtI™=0,469)
Qmax (ml/c) EPA group 9,2±0,3 (p^mR=0,042, pTLE=0,960) 15,7+0,4 ^^<0,001, pTUE=0,013)
EPA+TUR group 8ftiOA (Pepa=0,042, P™^,^) 19,2±0,3 0^0,001, P^HOOl)
TUR group 9fltS)2 ^=0,960, P™™11^,^) 17,4±0,3 ^=0,013, PEPA™<0/001)
IPSS scores EPA group 28,2±0,7 (ph;PAVIUI!=0,023, p[LR=0,992) 9,7±0,4 (p№Anm=0,002, prul<<0/001)
EPA+TUR group 24,1±0,6 (P^^, PI™=0,002) 5,8±0,3 (Pepa<0,001,Piue=0,782)
TUR group 27,9±0,9 (PEFA=0,992, P0*™^)^) 6,4±0,6 (PEPA=0,002, Pepa™=0,782)
QoL scores EPA group 4,8±0,2 ^^=0,987, p™=0,996) 1,8±0,2 (pep™=0/122/ p™M),896)
EPA+TUR group 4,7+0,1 (PEFA=0,987, PIUE=1,000) 1,3+0,2 ^=0,122,P™=0,346)
TUR group 4,7±0,2 (Pepa=0,996, PhPAVIU =1,000) 1,7±0,2 (Pkpa=0,896, Pkpahur=0,346)
PSA total (ng/ml) EPA group 5,9±1,1 (pEP™=0,499/ p™=0,136) 2,6+0,2 (p^^OtB, p™=0,404)
EPA+TUR group 4,3+0,5 (PEPA=0,499, Ptur=0,585) 1,6+0,2 (PKPA=0,003, P™=0,796)
TUR group 3,6±0,5 ^=0,136, p™™=0/585) 1,9±0,4 (Pepa=0,404, PwhmM=0,796)
TURP after EPA procedure was performed for a shorter period of time compared to the group without such preparation due to the reduction of prostate volume. Intraoperatively there lacked contact and diffuse tissue hemophilia in the process of TURP (Figure 4a and 4b). Standardized ratio of resection speed was significantly higher (p=0,023) in EPA+TUR group and constituted 43±0,04 g/min against 0,36±0,03 g/min in TUR group. In EPA+TUR group there was registered a smaller number of complications in comparison with TUR group.
The comparative evaluation of all three treatment methods is presented in Table 2. The interpretation of the table shows, that at the moment of inclusion into research all three groups were homogenous in terms of most parameters.
In EPA group the volume of prostatic gland after the conducted treatment in control period of observation turned out to be significantly higher compared to other groups 79,3±6,6 sm3
- EPA group, 21,5±0,7 sm3 - EPA+TUR group (p<0,001) and 22,4±0,8 sm3 - TUR group (p<0,001). Consequently, a significantly lower effectiveness was reached by suchcoefficients, as Qmax 15,7±0,4 ml/s - EPA group, 19,2±0,3 ml/s - EPA+TUR group, 17,4±0,3 ml/s - TUR group (p+0,013); the average number of IPSS scores 9,7±0,4 - EPA group, 5,8±0,3
- EPA+TUR group (p=0,002), 6,4±0,6 - TUR group (p<0,001). The results of other parameters turned out to be finally comparable.
These are the volume of residual urine 16,2±2,2 ml - EPA group, 14,7±1,9 - EPA+TUR group, 11,7±1,3 - TUR group, QoL (scores) 1,8±0,2 - EPA group, 1,3±0,2 - EPA+TUR group, 1,7±0,2 - TUR group. While the reduction of PSA total level was significantly higher in EPA+TUR group compared to EPA group (p=0,003), but in comparison with TUR group the average value was comparable (p=0,796).
Consequently, all three methods of treatment of benign hyperplasia of prostatic gland of large volume allow to reach the elimination of infravesicular obstruction and restoration of normal voiding function of the urinary bladder. In all cases Qmax by the control period of observation was higher than the threshold value by 15 ml/s, IPSS index in TUR and EPA+TUR groups reached the values typical of the mild symptomatology, in EPA group the average number of scores remained within the gradation of average symptom expression. QoL index characterizing patient's attitude to the disease reached the value lower than 2 in all groups, which corresponds to "good" and "perfect". This means, that the stated objective -the improvement of patient's life quality - is met in all cases.
Out of the three studied methods of treatment, EPA in isolated form possesses the lowest risk of complications threatening the life and health
of patient. None of the EPA group patients required rehydration therapy or blood component transfusion. The safety of EPA make it a preferable alternative in patients with risk of surgical intervention of III and IV degrees according to ASA.
Conclusion
Consequently, the analysis has shown, that the treatment of BHPG patients of large volume by all the presented methods brought satisfactory results, which allows to elaborate the following algorithm of the disease management in patients of the stated category.
The first stage of medical tactics, independent of clinical symptoms according to IPSS scale, by hyperplasia of prostatic gland with large volume it is necessary to exclude the state of patient requiring active operative tactics. By the existence of invariable indications of surgery, the patients with prostate volume bigger than 80 sm3 and high degree of operative and anaesthetic risk should be exposed to troacar cystostomy, while by the occurrence of concernments - cystostomy with the rupture of urinary bladder cavity and its revision.
By the lack of invariable indications of surgery or after the proper drainage of the urinary bladder, the therapy is reasonable to be started with the embolization of prostatic gland arteries. Further during the control periods of time there is evaluated the dynamics of change of prostatic gland volume, the improvement of quality indicators of urination - urofluometry, IPSS and QoL questionnaires. According to the conducted research, the highest degree of gland reduction occurs by the 3rd month of observation. If by the stated control point there has been observed a significant reduction of prostate volume, there exists a tendency of improvement of the patient's quality of life (IPSS and QoL) and also the improvement of urofluometry parameters, the tactics should consist in observation.
If by the 1st or 3rd month of observation the gland volume reached the value of 80 sm3 due to the reduction, the patient wants to remove the cystostomic drainage or to reach the radical recovery in short terms, the patients is exposed to TUR of prostate.
Thus, the schematic algorithm of treatment of patients with BHPG of large volume can be presented in the following way (Figure 5).
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Contacts:
656038, Barnaul, Lenina Prospect, 40.
Altai State Medical University.
Tel: (3852) 241859.
Email: zharikov@agmu.ru
