THE EXAMINATION OF THE QUALITY OF LIFE CHANGES OF PATIENTS REGARDING DIFFERENT METHODS OF TREATMENT OF STONES IN THE URINARY TRACT ISPITIVANJE PROMENE KVALITETA ŽIVOTA BOLESNIKA KOD RAZLIČITIH METODA LEČENJA KAMENA U URINARNOM TRAKTU

Introduction/Purpose: Urolithiasis is one of the most common urological illnesses with a continual rise in incidence and prevalence in the population. Its pathogenesis is multi-factor; hence, its consequences are serious problems that can significantly impact the quality of life of the patients. In the last years, operational modes of urolithiasis treatment had undergone evolution changes towards minimally invasive treatment techniques aimed at improving its efficacy and patients' life quality. The purpose of the study is to examine and evaluate the quality of life of the patients with urolithiasis depending on the applied treatment method.Methods: This research is designed as a panel study – a combination of a cross-sectional and cohort study. The sample included patients with urolithiasis treated with ESWL or ureteroscopic lithotripsy (Lithoclast).The research was carried during one year period and 100 respondents met the inclusion criteria. They were divided into two equal groups considering the applied method of the stone disintegration: Lithoclast Group (URSL) and ESWL Group. The instrument used for measuring the quality of life was SF 36 questionnaire. It was administrated to the patients immediately before the operation and one month after the operation.Results: The statistical analysis of the scores obtained preoperationally on the SF 36 questionnaire have revealed the decrease in the quality of life of patients with urolithiasis in almost all dimensions of life. The statistically relevant difference in preoperative SF scores between the two groups of patients was not established except in the domain of the role of physical health. In this domain, the Lithoclast group had a statistically significant higher score than the ESWL group. Furthermore, in the domain of mental health, the ESWL group had a statistically significant higher score than the Lithoclast group. The post-operative statistical analysis of SF questionnaires and the examination of the impact of the treatment mode on the quality of life have shown that the use of the Lithoclast method has resulted in the much higher, statistically significant score at SF36 questionnaires regarding several life dimensions. Hence, it has a statistically more significant impact on the enhancement of the quality of life of patients post-operatively regarding several life dimensions than the ESWL method. The application of the ESWL 5 method even resulted in the decrease in the post-operational score for some life dimensions.Conclusion: The assessment of the quality of life is an adequate tool for the evaluation of treatment modes in the clinical practice. One method of accomplishing it is to assess the patient's quality of life divided into different life dimensions through the highly reliable SF 36 questionnaire. By using the SF 36 questionnaire in this study, we established that the ureteroscopic lithotripsy (the Lithoclast method) is a method that results in much higher and statistically significant improvement of the life quality in several health domains than the ESWL method.


Apstrakt
Uvod/Cilj: Urolitijaza je jedno od najčešćih oboljenja u urologiji sa stalnim porastom incidence i prevalence u populaciji.Patogeneza ovog oboljenja je multifaktorijalna, a za posledicu ima veoma ozbiljne probleme koje mogu imati značajan uticaj na kvalitet života ovih bolesnika.Tokom prethodnih godina, hirurški modaliteti lečenja urolitijaze pretrpili su evolutivne promene u korist minimalno invazivnih tehnika lečenja u cilju postizanja bolje efikasnosti lečenja i poboljšanja kvaliteta života bolesnika.Cilj studije bio je ispitati i proceniti kvalitet života bolesnika sa urolitijazom u odnosu na pimenjenu metodu lečenja.Metode: Ispitivanje je dizajnirano kao panel studija (kombinacija studije preseka i kohortne studije).U studiju su bili uključeni bolesnici sa urolitijazom lečeni ESWL ili Ureterorenoskopskom litotripsijom (Lithoclast) u periodu od jedne godine od kojih je sto ispitanika je ispunilo kriterijume za uključivanje u studiju.Oni su podeljeni u dve grupe:Lithoclast grupa (URSL) i ESWL grupa.Kao instrument za merenje kvaliteta života korišćen je SF 36 upitnik koji su bolesnici popunjavali neposredno preoperativno i jedan mesec postoperativno.Rezultati: Analizom skora SF 36 upitnika preoperativno utvrdili smo da postoji smanjenje kvaliteta života kod bolesnika sa urolitijazom u gotovo svim dimenzijama života.Nije bilo statistički značajne razlike u preoperativnom SF skoru između dve grupe bolesnika izuzev domena uloge fizičkog zdravlja u kojoj je Lithoclast grupa imala statistički značajno viši skor od ESWL grupe i mentalnog zdravlja u kojoj je ESWL grupa imala statistički značajno viši skor od Lithoclast grupe.Statističkom anlizom SF 36 upitnika postoperativno i ispitivanjem uticaja modaliteta lečenja na kvalitet života, utvrdili smo da Lithoclast metoda postiže statistički značajno viši skor SF 36 u nekoliko dimenzija života i značajno utiče na poboljšanje kvaliteta života postoperativno u više dimenzija zdravlja u odnosu na ESWL metodu koja beleži blagi pad u skoru za neke dimenzije kvaliteta života postoperativnno.Zaključak: Procena kvaliteta života dobar je put za evaluaciju modaliteta lečenja u kliničkoj praksi.Jedan od načina da se to uradi jeste procena kvaliteta života bolesnika primenom upitnika SF 36.Primenom SF 36 upitnika u našoj studiji utvrdili smo da je ureterorenoskopska litotripsija (Lithoclast metoda) modalitet lečenja urolitijaze koja postoperativno daje statistički značajno poboljšanje kvaliteta života u nekoliko domena zdravlja u odnosu na ESWL metodu.Abstract Introduction/Purpose: Urolithiasis is one of the most common urological illnesses with a continual rise in incidence and prevalence in the population.Its pathogenesis is multi-factor; hence, its consequences are serious problems that can significantly impact the quality of life of the patients.In the last years, operational modes of urolithiasis treatment had undergone evolution changes towards minimally invasive treatment techniques aimed at improving its efficacy and patients' life quality.The purpose of the study is to examine and evaluate the quality of life of the patients with urolithiasis depending on the applied treatment method.Methods: This research is designed as a panel studya combination of a cross-sectional and cohort study.The sample included patients with urolithiasis treated with ESWL or ureteroscopic lithotripsy (Lithoclast).The research was carried during one year period and 100 respondents met the inclusion criteria.They were divided into two equal groups considering the applied method of the stone disintegration: Lithoclast Group (URSL) and ESWL Group.The instrument used for measuring the quality of life was SF 36 questionnaire.It was administrated to the patients immediately before the operation and one month after the operation.Results:The statistical analysis of the scores obtained preoperationally on the SF 36 questionnaire have revealed the decrease in the quality of life of patients with urolithiasis in almost all dimensions of life.The statistically relevant difference in preoperative SF scores between the two groups of patients was not established except in the domain of the role of physical health.In this domain, the Lithoclast group had a statistically significant higher score than the ESWL group.Furthermore, in the domain of mental health, the ESWL group had a statistically significant higher score than the Lithoclast group.The post-operative statistical analysis of SF questionnaires and the examination of the impact of the treatment mode on the quality of life have shown that the use of the Lithoclast method has resulted in the much higher, statistically significant score at SF36 questionnaires regarding several life dimensions.Hence, it has a statistically more significant impact on the enhancement of the quality of life of patients post-operatively regarding several life dimensions than the ESWL method.The application of the ESWL

Introduction
Urolithiasis is a common illness resulting in serious health problems that significantly impact the quality of life of patients. 1This illness represents a group of metabolic and endocrine disorders in the organism that together with changes in the urinary tract lead to the formation of stones and incurrence of urolithiasis.The incidence of urolithiasis in the global population is around 12 %. 2 Albeit it is found in all age groups, the highest incidence is among people in 3rd, 4th, and 5th decade of life.Moreover, it should be underlined that this illness is prone to recidivation.It is assumed that more than 50% of patients experience recidivation during the ten year period.Accordingly, urolithiasis is rightly labeled as "illness for the whole life." 2 The occurrence of urolithiasis is three times more common in men than in women. 3In the clinical practice, urolithiasis is most commonly classified according to the size and anatomic localization of the stone, which decisively impacts the decision on the mode treatment, or more precisely, the selection of the stone disintegration method.Today, indications and application of minimally invasive urological techniques dominant in the treatment of calculus in everyday clinical practice are clearly defined. 4,5Extracorporeal Shock Wave Lithotripsy (ESWL) is a method of the stone disintegration by the shock waves formed outside of the patient's body.Subsequently, they are focused on the stone.Currently, it is the most commonly used stone disintegration method. 6Ureteroscopic lithotripsy is a method that initially introduces a citoscope for the identification of ureter's orificium.Subsequently, a guide is used to introduce an ureteroscope to visualize and disintegrate the stone.For sure, these two methods had increased treatment efficacy and decreased the occurrence of complications.Today, they are primary modes of urolithiasis treatment. 7cording to numerous studies, symptoms related to the existence of urolithiasis, illness complications, chronicity, recidivism, and different treatment modes represent external factors that can significantly impact the quality of life of these patients. 5Regarding, the quality of life, it must be underlined that there is no widely accepted definition of this term nor the golden standard for its measurement. 8However, the most common definition is the 1 one proposed by the World Health Organization.Accordingly, it is an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns. 9In the dictionary "Health for Everybody for the 21st century," the quality of life is defined as a perception of individuals or groups that their needs will be recognized in time and met in order to achieve happiness and fulfillment. 10e term "the quality of life regarding health" describes the subjective satisfaction of an individual with his or her health status. 11In this case, the quality of life is a factor for exploration of the impact of the illness and treatment modes on an individual's health by integrating the objective assessment of the health status and subjective perception.
Accordingly, the examination of the quality of life is a crucial factor that complements laboratory and diagnostic treatment of patients and contributes to the assessment of the illness flow and treatment mode of life and functioning of individuals.Undoubtedly, the introduction of the term quality of life in the medical sign has enabled the medical practitioners to perceive a patient as a complete person and to prevent the division between the patient's body and his or her personality.Currently, the incidence of chronic illnesses is on the rise.Accordingly, the number of patients who are long-term beneficiaries of health care system services is increasing as well.As a consequence, the interest for exploration of the quality of life has gained prominence among researchers, considering that, evidently, it is a valuable source of information about the flow, the success rate of the treatment modes, and the outcome of the illness..The patients filled it in independently; however, in the presence of a doctor whose role was to clarify the questions.SF 36 is an instrument for measuring individual perceptions of the overall health condition, the ability of functioning, limitations caused by emotional problems, limitations caused by physical problems, pain, fatigue, and problems in social functioning.The questionnaire consists of 36 questions divided into eight health domains regarding the 4week period: physical functioning, limitations due to physical health, bodily pain, overall health, social functioning, limitations due to emotional problems, and mental health. 13swers in each domain were scored.The scale of answers was represented by numbers from 0 (the worst) to 100 (the best).Thus, the higher value indicated a higher quality of life better physical functioning, better physical role, absence or lesser bodily pain, improved overall health, higher vitality, better social functioning, improved the emotional role and better mental health.The Cronbach analysis was used to test the reliability of the SF 36 questionnaire.More precisely, it tested the reliability of scales of given groups of the features.The testing confirmed the internal consistency of questions and reliability of the measurement instrument. 14Descriptive and analytical statistic methods were used to analyze and present the obtained data.Concerning descriptive methods, absolute and relative numbers, measures of central tendency (arithmetic mean, median), and measures of dispersion were used (standard deviation).Also, the following analytical methods were used: tests of difference (Hi-Quadr test, t-test, Mann-Whitney U test) and correlation analysis.SPSS 21.0 (IBM) program was used for data analysis.

Results
The following results were obtained from the data analysis.An overview of the basic demographic characteristics of patients divided into groups is shown in Table 1.
The average age of respondents in this study is 50.The youngest respondent was 20 and the oldest 70 years.The sample included 60% of male and 40% of female respondents.Statistically significant differences regarding age and gender were not revealed.However, the data analysis demonstrated statistically significant differences regarding the value of BMI (Body mass index).Concerning comorbidity, 46% of respondents did not report accompanying comorbidities; 32% reported hypertension; 11% diabetes, and 11% other accompanying illnesses such as angina pectoris, depression, rheumatism, and disorder of a thyroid gland.The statistically significant differences between the two groups were not noted (Table 2).
The significant distribution of patients by groups existed depending on urological diagnosis pre-operationally.Hence, the kidney stones (renal calculi) were prevalent in the ESWL group, whereas ureteral calculus was more dominant in the Lithoclast method.
As shown in Tables 3 and 4, the statistically significant difference was noted regarding the localization of the stone and present symptoms of urolithiasis pre-operatively.Calculus of urinary tract is accompanied by intense distress and symptoms requiring an adequate treatment (Table 4).According to the patients, the most unpleasant symptom of urolithiasis is renal colic, as it is very painful for each patient. 15e SF scale of answers was used for the assessment of the quality of life of patients preoperatively and post-operatively.The scale of answers was represented by numbers from 0 (the worst) to 100 (the best).Thus, the higher value indicated a higher quality of life (Table 5).
The statistical analysis of pre-operative SF 36 questionnaires has revealed that patients with urolithiasis in both groups have lower SF 36 score of the quality of life in almost all dimensions or domains of health.The particularly low score was attained in the domain of physical functioning in Lithoclast group.This score was statistically significantly lower in comparison to the patients of the ESWL group.The low scores were also noted in the following health dimensions: bodily pain, overall health, vitality, emotional role, and mental health.The statistically significant difference in SF 36 score pre-operatively has been proven in the domain of mental health as well, as the ESWL obtained a higher score than the Lithoclast group.
Considering the impact of the treatment mode of urolithiasis on the quality of life of respondents post-operatively, we have established statistically significant differences in the patients' quality of life between two groups in several dimensions of health.Ureteroscopic lithotripsy has outperformed the ESWL method in the following dimensions: physical functioning, a role of physical functioning, bodily pain, vitality, social functioning, and mental health.The patients in the ESWL group even experienced a lower SF score (the negative impact on the quality of life) in the following dimensions: mental health, vitality, social functioning, and the role of physical functioning.The exceptionally high statistically significant difference regarding the higher score (better quality of life), the Lithoclast group has attained in three health domains: physical functioning, social functioning, and bodily pain.

Discussion
The demographic characteristics of the patients in this study regarding age, gender, BMI (body mass index), the frequency of urolithiasis considering age and gender, as well as the most common and the most significant symptoms of this illness, correspond to the results of previous studies on urolithiasis.Until recently, only several studies examining the quality of life of patients with urolithiasis had been published. 16The examination of the quality of life in urology started in 1992, following the recommendation of the American Urological Association to include questionnaires on the patients' quality of life in urological research.Initially, research focused on patients with prostate and malign illnesses, whereas the quality of life of patients with urolithiasis had remained unexplored due to a limited number of studies on this issue. 16,17,18cording to the literature review, the majority of authors analyzes and evaluates the quality of life of individuals regarding the functional ability, degree, and quality of social interaction, mental wellbeing, somatic sensations, and life satisfaction. 18.However, the authors commonly argue that although objective assessment of health is important for the quality of life depends on health, also a subjective assessment of the health of the patient as well as his or her expectations of the treatment and the treatment outcome should be taken into account.
One of the most challenging aspects of measuring the quality of life is a quantification of all components and domains of health.To enhance the efficacy of measurements of different domains of the quality of life through specific questions, the fundamental measures were developed, namely, measures of psycho-physical condition and measures of the perceptions of sensations. 17One of the instruments frequently used in practice is SF 36 questionnaire for the examination of the quality of life.In the recent years, several studies have used this questionnaire.The study of Donnelly et al. examined the quality of life of patients with utolithiasis 18. Nine studies on 1570 patients with urolithiasis also used SF 36 questionnaire as an instrument for measuring the quality of life 19.In our study also employed SF 36 questionnaire, considering that numerous previous studies have confirmed its psychometric validity for measuring the quality of life 20 .In this study, the statistical analysis of SF 36 scores pre-operatively has established that patients with urolithiasis in both groups have a lower quality of life in all dimensions or domains of health.In particular, the lowest score of the SF 36 questionnaire was attained pre-operatively in the domain of physical health in the Lithoclast group.This score was statistically significantly lower than the score of patients in the ESWL group.Accordingly, prior to the intervention, patients in the Lithoclast group had much more problems in work and in fulfilling daily activities due to lower physical health.The lower score was also noted in the following dimensions of health: bodily pain, overall health, vitality, emotional role, and mental health.The statistically significant difference in SF score pre-cooperatively between two groups has also been proven in the domain of mental health, as the patients from the ESWL group had higher scores than those of the Lithoclast group.More precisely, the patients from the ESWL group reported being nervous and felt less depressed.The results of this study are in line with those of the similar studies carried out abroad. 21Seven studies on the quality of life of patients with urolithiasis confirmed the decreased quality of life. 19Although there are variations among studies, it can be argued that patients with urolithiasis have a lower quality of life in comparison to the general population [22][23][24] .According to the study of Bryant et al., patients with urolithiasis have a significantly lower SF 36 score than the general US population in six out of eight domains of health. 16This study also confirmed that the SF 36 questionnaire is a valid instrument for the assessment of the quality of life.However, a lack of the baseline SF 36 questionnaire for the healthy population in Serbia poses a significant challenge for the researchers, as it is not possible to carry out comparisons.Considering the impact of the treatment mode of urolithiasis on the quality of life of respondents postoperatively, there is a lack of relevant studies.Moreover, the study results are varied and even conflicting. 23,24Conclusion is that in spite of various treatment modes of urolithiasis and their high efficacy, further research in this area is needed to improve the postoperative outcomes of the models and the quality of life of patients. 25,26is study demonstrated through the statistical analysis of SF 36 questionnaires filled in by the patients four weeks after the operation that there is a statistically significant difference regarding the quality of life of patients post-operatively between two groups of patients (the treatment mode of urolithiasis) in several domains of health.With the higher score on SF 36 questionnaire, ureteroscopic lithotripsy outperformed the ESWL method in the following dimensions: physical functioning, the role of physical functioning, bodily pain, vitality, social functioning, and mental health.Concerning daily clinical practice, it is concluded that patients treated by ureteroscopic lithotripsy had fewer limitations in performing physical activities, fewer problems at work and other activities due to the physical health; reduction or elimination of bodily pain, and fewer problems in social functioning due to emotional and economic difficulties.Moreover, they were more vital and less nervous and depressed, unlike the patients in the ESWL group, who even experienced a lower SF score (the negative impact on the quality of life) in the following dimensions: mental health, vitality, social functioning, and the role of physical functioning.
The exceptionally high statistically significant difference regarding the higher score (better quality of life), the Lithoclast group has attained in three health domains: physical functioning, social functioning, and bodily pain.This study has shown that ureteroscopic lithotherapy as a treatment mode of urolithiasis is much more efficient than the ESWL mode.Moreover, it has a more positive impact on the quality of life of patients after the intervention.

Conclusion
The treatment of urolithiasis, its chronicity and the impact on the quality of life of those patients represents a challenging for selecting the right treatment mode.Indications and contraindications for performing the ESWL or ureteroscopy (URSL) are very similar and sometimes even identical; thus, posing a great challenging for the clinical practice.The assessment of the quality of life is as a recommended method for the evaluation of treatment modes as it allows their measurement and comparison.The assessment of the quality of life-related to health enables the healthcare practitioners to perceive the patient not only as a carrier of illness but as a personality as well.The SF 36 questionnaire is a highly reliable tool for assessing the quality of life by measuring different dimensions.This study confirmed that is a valid measurement instrument.The study demonstrated that ureteroscopic lithotripsy is a treatment mode of urolithiasis that post-operatively results in statistically significant enhancement of the quality of life of patients in several health domains in comparison to the ESWL method.Moreover, it has contributed to the field of study by providing the basis for further research aimed at faster and more optimal decisionmaking process about efficient and safe treatment methods of urinary calculosis that should in addition to healing also improve the life quality of patients post-operatively.
Ključne reči: urolitijaza, modaliteti lečenja, kvalitet života, SF 36 upitnik Abstract The Examination of the Quality of Life Changes of Patients Regarding Different Methods of Treatment of Stones in the Urinary Tract This research is designed as a panel studya combination of a cross-sectional and cohort study.The sample included patients with urolithiasis of the Urology Clinic of the Clinical Center of Serbia treated with ESWL or ureteroscopic lithotripsy (URSL apparatus Lithoclast), on the basis of the decision of the Calculosis Consilium, following the recommendations of the European Association of Urologists.Our research did not affect the decision of the Consilium on the applied method.The research was carried out between February 1, 2017 and February 1, 2018, and 100 respondents met the inclusion criteria.They were divided into two equal groups considering the applied method of the stone disintegration: Group 1 or Lithoclast Group (URSL) and Group 2 or ESWL Group, each with 50 respondents.The following were the criteria for inclusion in the study: the patients with the diagnosis of urolithiasis, older than 18 who gave consent to participate in the study and who are members of the group ASA I-III.The study excluded patients who did not want to participate, patients with ASA score 4 and 5, individuals with heavy injuries and illnesses and heavy infections of the urinary tract, patients with hemorrhagic diathesis, and patients with contraindication (according to the recommendation of the European Association of Urologists) for performing one of those methods.The instrument used for measuring the quality of life was SF 36 questionnaire.It was administrated to the patients immediately before the operation and one month after the operation during the control checkup.This study used linguistically and culturally adapted and validated Serbian version of SF 36 questionnaire (Proqualid Patient-reported outcome Quality of life instruments Database SF 36 Health Survey Serbian Version accessed on 20 June 2012) millimetar lower pole renal stone:medium follow-up results.Int Braz J Urol 2018; Vol 44:(x):doi: 10.1590/S1677-5538.IBJU.2017.0483(Ahead of print)