Urolithiasis DOI 10.1007/s00240-014-0727-3
ORIGINAL PAPER
How do the residual fragments after SWL affect the health‑related quality of life? A critical analysis in a size‑based manner Cahit Sahin · Alper Kafkasli · Cihangir A. Cetinel · Fehmi Narter · Erkin Saglam · Kemal Sarica
Received: 22 May 2014 / Accepted: 21 August 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract This study aimed at evaluating the possible effects of residual fragments (RF) after shockwave lithotripsy (SWL) on the health-related quality of life (QOL) of the patients on a size-related basis. Eighty six patients with RF after SWL were divided into three groups: Group 1 (n:30 with fragments ≤2 mm), Group 2 (n:21 2–≤4 mm) and Group 3 (n:35 > 4 mm). During a 3-month follow-up, spontaneous passage rates, emergency department visits, mean analgesic required, additional procedures and the QOL were all evaluated. QOL was evaluated using the Short Form-36 survey. Of the 30 patients with fragments ≤2 mm all cases passed the fragments spontaneously. Of the 21 cases with fragments 2–≤4, however, 76 % were stone free. Last, of the 35 cases with fragments >4 mm, 52 % passed them spontaneously in 3 months. While no patient with fragments ≤2 mm required emergency department visit, 19 % of the cases with fragments 2–≤4 mm and 51.4 % with fragments >4 mm did require this visit. Mean analgesic need (mg) values were higher in cases with larger fragments. Evaluation of the QOL score data in a subgroup comparison base showed that cases with larger fragments had prominently lower scores during both 1- and 3-month evaluation. RF after SWL could pose an impact on the QOL of the cases in a size-related basis. While fragments ≤2 mm had nearly no impact on this aspect larger fragments could significantly affect the QOL. C. Sahin · A. Kafkasli · C. A. Cetinel · F. Narter · E. Saglam · K. Sarica Urology Clinic, Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey C. Sahin (*) Gömeç sok, Sabancı ‑2 Sitesi A1 Kat 4 Daire 24 Acıbadem, Kadıköy, Istanbul, Turkey e-mail: [email protected]
Keywords Renal · Stones · SWL · Residual fragment sizing · Quality of life
Introduction Urolithiasis is still a common health problem in developing countries (1–5 %) [1, 2]. The lifetime prevalence of the disease is 12 % in men and 6 % in women in USA [3] where it typically affects the social life of the cases during 20 and 50 years [3–5]. Distressing pain, obstruction, recurrent infections, loss of work time or employment are the welldocumented problems related particularly with recurrent urolithiasis [6]. Concerning these bothersome symptoms, however, limited literature data are present regarding the health-related quality of life (QOL) of these patients. Despite a successful disintegration of the calculi by minimally invasive procedures (each of which may be associated with some certain advantages and disadvantages) [7], residual fragments (RF) can be detected in a considerable percent of the cases. The associated symptoms and morbidity with these fragments may have significant effects on the QOL of the patients [4, 5]. Among these, regarding the clinical course of the RF after extracorporeal shockwave lithotripsy (SWL) a number of studies revealed either stone regrowth and/or associated bothersome symptoms and retreatment in a considerable percent of these cases [8–11]. Thus, irrespective of the stone-related factors, endourologists should not only solely focus on the success rates but also on the presence and possible effects of RF on the psychological, functional, social life of the patients [12, 13]. Quality of life is an estimate of freedom from impairment, disability or handicap [14]. The concept of healthrelated QOL is multidimensional and includes psychosocial, physical and emotional status, as well as patient
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autonomy and is applicable to a wide variety of medical conditions [13, 15–18]. Although QOL of the cases has been well assessed and evaluated in a variety of diseases and/or procedures, to our knowledge, limited studies investigated the possible effects of RF on the QOL in patients with RF after certain stone removal procedures. Available studies on this aspect are limited to those involving patient preferences in the treatment of urinary stones, stent placement and QOL following SWL procedure or other surgical modalities [16, 19, 20]. In this prospective study we aimed to evaluate the possible effects of RF after SWL on the QOL of the treated patients on a size-related basis using Short-Form 36-item survey (SF-36) quastionnaire.
Patients and methods Between February 2012 and March 2013, a total of 86 patients (61 men, 25 women; M/F: 2.4) presenting with RF after SWL for solitary renal pelvis stones sizing 10–25 mm were evaluated in a prospective manner with a 3-month follow-up period. Patients with ureteral calculi, complex renal anatomy, transplant kidneys, medullary sponge kidneys, parenchymal calcifications, urinary diversion, cystine or struvite stones, pregnancy, bleeding diathesis or in need for anticoagulants were all excluded from the study program. Following the first session of SWL, patients were divided into three subgroups with respect to the largest RF size: Group 1 (n:30) Patients with RF sizing ≤2 mm, Group 2 (n:21) 2–≤4 mm and Group 3 (n:35) patients with RF sizing >4 mm. SWL procedure was performed under sedoanalgesia (Fentanil, 1.5 µg/kg) by an electromagnetic (Dornier Compact Sigma, Dornier MedTech Germany) lithotriptor with a maximum SW number of 3,000/session at 120 kV values. All procedures were performed on an outpatient basis and the overall stone-free (SF) status has been assessed at 3 months. Following a week after SWL, first plain KUB and sonography were performed in all cases and NCCT was performed in a case-dependant manner to assess the presence and size of the RF if needed. All cases were followed for 3 months and spontaneous passage rates, number of emergency departments (ED) visits, the amount of the analgesic required (Diclofenac sodium 75 mg IM at each referral), additional procedures for symptomatic and/or obstructing fragments and the changes in the QOL were well assessed. The impact of the RF on QOL was evaluated from different aspects after 1 and 3 months by giving SF-36 questionnaire filled at hospital conditions. To determine the significance of the differences between our sample population and those of Turkish healthy volunteers; the overall QOL scores of the subgroups were first compared
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with the scores of healthy Turkish volunteers before making the inter subgroup comparisons which has been derived from a cross-sectional study of 1,279 persons (18 years old or older) without any chronic disease during both 1- and 3-month follow-up [21]. The Medical Outcome Study SF-36 Turkish version1.0 was used to assess QOL [22]. This questionnaire consists of 36 self-administered questions that quantify QOL using eight multi-item scales: General health (GH), Physical functioning (PF), Role physical (RP), Bodily pain (BP), Vitality (VT), Social functioning (SF), Mental health (MH) and Role emotional (RE) [23].The eight scales were scored separately from 0 to 100, with a higher score being indicative of a better result, and these scores were used for analyses of the comparisons among the groups. All analyses were performed using NCSS 2007 & PASS 2008 Statistical Software program. SF-36 domains were compared among subgroups by potential predictors and significance was tested by the Student’s t test. Evaluation of qualitative data was done with Yates Continuity Correction test. Moreover, to evaluate the mean group values of normally distributed parameters in more than two subgroups One-Way ANOVA test and Tukey HD test were used for Post Hoc analysis. Significance was considered as p 4 mm in 35 cases (41 %). KUB, sonography and NCCT (when necessary) were performed in the diagnosis and follow-up of RF. Depending on the clinical course of RF additional procedures like repeat SWL, ureteroscopy with intracorporeal lithotripsy (URS) and double-J stent (DJ) were performed in symptomatic cases. Regarding the composition of the stones, analysis of data was available in 55 patients and majority of them had calcium containing stones [Calcium oxalate monohydrate in 32 (58.2 %), calcium oxalate dihydrate in 13 (23.6 %) and mixed calcium stones in 10 (18.2 %)]. Evaluation of our data revealed following findings Patients with RF ≤2 mm All 30 cases with RF sizing ≤2 mm passed fragments (in an asymptomatic manner in 25 cases) spontaneously
Urolithiasis Table 1 Evaluation of patient and stone characteristics in all groups
Number of cases n (%) Mean age (years) Male/female Initial stone size (mm)
Overall
Group 1
Group 2
Group 3
86 (100)
30 (35)
21 (24)
35 (41)
40.7 61/25 12.5 (10–25)
42.2 (20–67) 21/9 10.7 (10–13)
40.0 (25–57) 15/6 11.5 (10–17)
40.0 (22–65) 25/10 15.2 (11–25)
Group 1 (≤2 mm)
n (%)
Mean RF size (mm)
Number of cases Spontaneous passage after first session of SWL Without any symptom With clinical symptoms requiring medical management Patients with symptoms requiring intervention Overall (After 3 months) stone free
30 (35) 30 (100) 25 (83) 5 (17) 0 (0) 30 (100)
1.8 (1.2–2.0) 1.8 (1.2–2.0) 1.6 (1.2–2.0) 1.9 (1.7–2.0)
Group 2 (2–≤4 mm) Number of cases Spontaneous passage after first session of SWL
21 (24) 11 (52)
3.6 (2.2–4.0) 3.3 (2.2–3.9)
Without any symptom With clinical symptoms requiring medical management Patients with symptoms requiring intervention Required intervention in these cases ESWL URS Overall (After 3 months) stone free Asymptomatic residual fragments
3 (14) 8 (38) 10 (48)
3.2 (2.2–3.8) 3.4 (3.1–3.9) 3.9 (3.4–4.0)
8 (38) 2 (10) 18 (86) 3 (14)
3.8 (3.4–4.0) 3.9 (3.9–4.0) 3.75 (3.7–3.8)
Group 3 (>4 mm) Number of cases Spontaneous passage after first session of SWL Patients with persistent fragments(requiring intervention) Required intervention in these cases ESWL URS DJ stent insertion Overall (After 3 months) stone free Asymptomatic residual fragments
within 4 weeks. Mean size of the fragments was 1.8 mm (1.2–2 mm). Although five cases (17 %) received pain medication (Medical expulsive treatment, analgesic medication); no additional procedure was necessary in these cases (Table 1). Patients with RF sizing 2–≤4 mm Of the 21 patients in this group, 11 (52 %) passed the fragments spontaneously during the first month while symptoms necessitated additional intervention in the remaining 10 (48 %) patients. The mean size of the fragments in these two subgroups is given in Table 1. In symptomatic patients while SWL was performed in eight cases (38 %),
35 (41) 11 (31) 24 (69)
5.6 (4.1–9.5) 4.8 (4.1–5.2) 6.4 (4.4–9.5)
14 (40) 7 (20) 3 (9) 30 (86)
6.7 (4.7–6.4) 7.1 (4.4–9.5) 5.4 (4.4–5.9)
5 (14)
3.5 (1.9–4.5)
URS was done in two cases (10 %). Following SWL, however, although five cases (23.8 %) became ultimately SF, three cases had still asymptomatic RF(14 %). Last, two cases (6 %) became SF after ureteroscopic Stone removal (Table 1). Overall, while three cases (14 %) had RF the remaining 18 cases (86 %) were completely SF after 3 months. Patients with RF >4 mm Of the 35 cases in this group, while 11 cases (31 %) passed RF spontaneously within a mean time period of 3 weeks (1–4 weeks), 24 cases (69 %) had sypmtomatic fragments. While SWL was performed in 14 cases (40 %), URS was
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Urolithiasis Table 2 Mean analgesic requirement and emergency department (ED) visits in the symptomatic cases in all groups Residual fragment size
ED visit No Yes Mean analgesic required, Ort ± SD (mg)
≤2 mmd
2–≤4mme
>4mmf
n = 30 (%)
n = 21 (%)
n = 35 (%)
30 (100 %) 0 (0 %)
17 (81 %) 4 (19 %)
17 (8.6 %) 18 (51.4 %)
15.00 ± 0.58
141.00 ± 1.05
258.75 ± 2.61
p
p = 0.001a p1–2–3 = 0.001b p1–2 = 0.011c p1–3 = 0.001c p2–3 = 0.015c
a
Pearson Ki-kare test
b
One-way anova test
c
Post Hoc test: Tukey HSD test
d
Group 1
e
Group 2
f
Group 3
performed in 7 (20 %) and DJ stent insertion in three cases (9 %). Mean size of the fragments in these three subgroups are given in Table 1. Following SWL, while nine cases (26 %) became SF within 6 weeks (1–8 weeks), five cases still had asymptomatic RF (14 %). After two sessions of SWL again, although 20 cases (57 %) became completely SF, five cases (14 %) had still RF. Last, all seven cases (20 %) undergoing URS and the three cases (9 %) with DJ stent insertion became SF (Table 1). Analgesic use and ED visits Our data showed that patients with RF >4 mm required a higher mean amount of analgesic use when compared with the second and first groups of patients. Regarding the mean number of ED visits again while the mean percentage was 0 % in cases with fragments ≤2 mm, it was 19 % in 2–≤4 mm and 51.4 % in >4 mm (p = 0.001), respectively (Table 2). Data on QOL evaluated by SF‑36 survey Regarding the evaluation of patient-related QOL, first we compared the overall QOL scores in all subgroups with healthy volunteers during 1 and 3 months of evaluation. Data obtained during 1-month evaluation demonstrated significantly lower scores with respect to seven parameters (GH, PF, RP, BP, VT, SF and RE) in cases with RF; however, this difference was significantly lower for only two parameters (SF, RE) during 3 months’ evaluation (Fig. 1). Additionally, this evaluation has been performed in all subgroups in a size-based manner and while there was significantly lower scores for only two parameters (GH and BP) during 1 month evaluation (Table 3), significantly lower mean scores for all eight parameters were noted between three subgroups in a
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size-based manner where patients with larger fragments had the lowest scores during 3-month evaluation. Evaluation of the scores in a sub-group based manner showed significant differences depending on the mean size of the RF. Although evaluation of QOL parameters between first two groups (mean RF size of ≤2 mm and 2–≤4 mm) revealed a significant difference with lower scores in all eight fields of QOL in favor of larger fragments (2–≤4 mm) during 1-month evaluation, (Table 3) this diferrence was statistically significant for only three fields (GH, BP, VT and) with significance values of p = 0.035, p = 0.022 and p = 0.031, respectively. However, mean QOL score values of these two groups have been found to be similar during 3-month evaluation. On the other hand, comparison of the last two groups (mean size 2–≤4 mm and >4 mm) showed that while there was no significant difference with respect to all eight fields of QOL during 1-month evaluation, there was a significant difference with lower scores in six fields [RP (p = 0.045), BP (p = 0.001), VT (p = 0.020), SF (p = 0.026), MH (p = 0.005) and RE (p = 0.044)] in favor of patients with larger fragments (>4 mm) during 3-month evaluation. Most importantly, we noted that although the mean scores of the cases with RF sizing ≤2 mm were nearly similar to normal population values during 3-month evaluation,; cases with larger fragments (2–≤4 mm and also >4 mm) had still significantly lower scores than these cases possibly due to the stone-induced symptoms and additional procedures.
Discussion Urolithiasis is a major problem particularly in endemic countries [1, 2]. A proper management plan and efficient
Urolithiasis Table 3 Evaluation of the health-related quality of life scores in three groups as a whole during 1- and 3-month follow-up Size of residual fragment
GH 1 month 3 months PF 1 month 3 months RP 1 month 3 months BP 1 month 3 months VT 1 month 3 months SF 1 month
p
≤2 mm (n = 30)
2–≤4 mm (n = 21)
>4 mm (n = 35)
Ort ± SD
Ort ± SD
Ort ± SD
71.18 ± 14.66 78.51 ± 12.28
49.34 ± 14.58 72.87 ± 10.98
45.11 ± 12.52 64.08 ± 13.74
0.001 0.001
76.90 ± 22.15 88.90 ± 5.54
74.03 ± 12.72 88.15 ± 9.70
74.64 ± 18.81 82.91 ± 11.23
0.865 0.043
76.90 ± 16.04 88.60 ± 6.63
70.50 ± 17.32 89.32 ± 4.85
72.57 ± 15.44 80.16 ± 18.22
0.412 0.024
62.51 ± 16.47 87.16 ± 6.82
48.35 ± 19.65 88.54 ± 5.55
61.20 ± 17.62 74.39 ± 17.53
0.028 0.001
66.50 ± 18.26 83.30 ± 9.80
55.21 ± 15.05 83.44 ± 1.13
59.47 ± 16.55 72.57 ± 15.44
0.067 0.004
76.10 ± 13.56
70.50 ± 18.71
73.26 ± 15.79
0.527
3 months MH 1 month 3 months RE 1 month
88.90 ± 5.54
90.50 ± 0.00
84.98 ± 10.55
0.040
73.70 ± 12.49 88.10 ± 6.63
70.50 ± 14.14 89.32 ± 4.85
65.57 ± 17.45 78.78 ± 15.60
0.152 0.002
68.90 ± 17.24
58.15 ± 19.85
69.12 ± 15.97
0.983
3 months
88.90 ± 5.54
89.32 ± 4.85
82.22 ± 14.66
0.026
One-way variance analysis GH general health, PF physical functioning, RP role-physical, BP bodily pain, VT vitality, SF social functioning, MH mental health, RE roleemotional
stone removal are the main steps. Despite a successful Stone disintegration, however, RF after certain stone removal procedures can cause a variety of distressing symptoms with recurrent stones in about 70 % of patients within 20 years [24]. Colic pain, obstruction and recurrent infections are most commonly encountered problems [6]. Related with this subject, today little is known about the QOL of patients with RF after endourological procedures. Although the stones can be treated in a safe and quick manner with minimally invasive procedures [7] and the “SF” status is the ultimate aim, published data demonstrated that RF could be detected in a certain percent of the cases. Studies with long-term follow-up data reveal that 24–36 % of the cases will have RF up to 3 months after SWL [9, 10]. Concerning the of RF, particularly after SWL, although they were assumed as an acceptable therapeutic end point, accumulated data so far suggest that RF may grow and cause symptoms requiring auxiliary procedures [25].
Regarding the ongoing debate for the definition and the management of RF, the major issue is whether the physicians need to aggressively treat them for a completely SF status or is it possible to follow these patients closely. However, associated symptoms and morbidity casued by these fragments could constitute significant effects on patients’ QOL in different ways [4, 5]. Published data demonstrated that although the majority of the fragments may remain asymptomatic, at least a certain percent may cause serious symptoms due to acute dislodgement, obstruction and infection. They may necessitate pain management, ED visits, hospitalization, or even removal [26] that may usually significantly affect the long-term QOL of such cases. Some investigators reported that a substantial number of these cases will experience a symptomatic episode requiring additional intervention within 2 years after SWL [17, 27]. Related with this subject, in their study Raman et al. [28] showed that the size of post-PNL RF correlates with
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Urolithiasis
100 90 80 70 60 50 40 30 20 10 0 Normal healthy Turkish volunteers Overall group values at 1-month Overall group values at 3-month
#
''
# #
''
#
#
#
#
GH 71.6 51.3 70.8
PF 83.8 74.8 85.8
RP 86.3 73.1 84.7
BP 82.9 58.1 81.8
VT 64.5 60.4 78.5
SF 91 73.1 87.2
MH 71 69.2 84.1
RE 90 68.3 85.8
Fig. 1 Evaluation of the QOL scores between volunteers and overall values of the whole group during 1 and3 months. (’’, #) Statistically significant differences (p < 0.05) determined from Student t test between Normal Turkishvolunteers and residual fragments group. GH
general health, PF physical functioning, RP role-physical, BP bodily pain, VT vitality, SF socialfunctioning, MH mental health, RE roleemotional
stone-related events where larger fragments were more likely to require secondary intervention. Again, Streem et al. [27] reviewed the natural history of small (4 mm had still significantly lower scores than these cases possibly due to the stone-induced symptoms and additional procedures performed. Thus, the evaluation of QOL after 3 months is more reliable by giving the chance to evaluate the affect of additional procedures on this parameter which are mostly performed within 4 weeks after SWL. Our findings in turn again led us to discuss the possible effects of RF on the QQL of the patients and open the true importance of clinical significance of RF assessed and interpreted only based on their size (that was done in the majority of published studies so far) for discussion. Depending on the size of the RF, we should re-think about the clinical significance of them, particularly taking the bothersome changes in patients QQL into account. It was clear that as the size of the fragments increase on one side the changes in QOL became evident and on the other side the need for analgesic use and the number of ED visits increased in a significant manner. Thus, as a crucial factor, QQL alterations noted in patients with RF should be as important as the size of the fragments to outline the “clinical significance” of these fragments indicating two main facts concerning the management of stones with SWL. First the endourologists should plan a careful patient selection in a stone size-based manner to limit the possibility of RF formation after endourological intervention and management should be performed preferably by an experienced urologist. The presence as well as the size of the RF should be closely evaluated and followed after treatment. Last, taking the limited possibility of passage of relatively larger fragments (>4 mm) into account; urologists could plan to treat these larger fragments on time rather than waiting for spontaneous passage. Concerning the limitations of our study, the number of cases evaluated could be the only certain limitation. However, as this study is the first one in the literature evaluating the possible effects of RF on the QOL after SWL in a sizebased manner. we believe that our study will certainly give an idea in defining the clinical significance of the RF and their true effects on QQL, a topic which was not evaluated in detail so far.
Conclusions Despite a successful stone disintegration, relatively larger RF (2–≤4 mm and >4 mm) after SWL could significantly affect the QOL of these cases. Colic pain requiring possible ED visits and analgesic intake and the additional
procedures for fragment removal are the main causes of discomfort. A well planned and effective management by an experienced urologist should be aimed in the treatment of stones with SWL. Conflict of interest We have no conflict of interest.
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ORIGINAL PAPER
How do the residual fragments after SWL affect the health‑related quality of life? A critical analysis in a size‑based manner Cahit Sahin · Alper Kafkasli · Cihangir A. Cetinel · Fehmi Narter · Erkin Saglam · Kemal Sarica
Received: 22 May 2014 / Accepted: 21 August 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract This study aimed at evaluating the possible effects of residual fragments (RF) after shockwave lithotripsy (SWL) on the health-related quality of life (QOL) of the patients on a size-related basis. Eighty six patients with RF after SWL were divided into three groups: Group 1 (n:30 with fragments ≤2 mm), Group 2 (n:21 2–≤4 mm) and Group 3 (n:35 > 4 mm). During a 3-month follow-up, spontaneous passage rates, emergency department visits, mean analgesic required, additional procedures and the QOL were all evaluated. QOL was evaluated using the Short Form-36 survey. Of the 30 patients with fragments ≤2 mm all cases passed the fragments spontaneously. Of the 21 cases with fragments 2–≤4, however, 76 % were stone free. Last, of the 35 cases with fragments >4 mm, 52 % passed them spontaneously in 3 months. While no patient with fragments ≤2 mm required emergency department visit, 19 % of the cases with fragments 2–≤4 mm and 51.4 % with fragments >4 mm did require this visit. Mean analgesic need (mg) values were higher in cases with larger fragments. Evaluation of the QOL score data in a subgroup comparison base showed that cases with larger fragments had prominently lower scores during both 1- and 3-month evaluation. RF after SWL could pose an impact on the QOL of the cases in a size-related basis. While fragments ≤2 mm had nearly no impact on this aspect larger fragments could significantly affect the QOL. C. Sahin · A. Kafkasli · C. A. Cetinel · F. Narter · E. Saglam · K. Sarica Urology Clinic, Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey C. Sahin (*) Gömeç sok, Sabancı ‑2 Sitesi A1 Kat 4 Daire 24 Acıbadem, Kadıköy, Istanbul, Turkey e-mail: [email protected]
Keywords Renal · Stones · SWL · Residual fragment sizing · Quality of life
Introduction Urolithiasis is still a common health problem in developing countries (1–5 %) [1, 2]. The lifetime prevalence of the disease is 12 % in men and 6 % in women in USA [3] where it typically affects the social life of the cases during 20 and 50 years [3–5]. Distressing pain, obstruction, recurrent infections, loss of work time or employment are the welldocumented problems related particularly with recurrent urolithiasis [6]. Concerning these bothersome symptoms, however, limited literature data are present regarding the health-related quality of life (QOL) of these patients. Despite a successful disintegration of the calculi by minimally invasive procedures (each of which may be associated with some certain advantages and disadvantages) [7], residual fragments (RF) can be detected in a considerable percent of the cases. The associated symptoms and morbidity with these fragments may have significant effects on the QOL of the patients [4, 5]. Among these, regarding the clinical course of the RF after extracorporeal shockwave lithotripsy (SWL) a number of studies revealed either stone regrowth and/or associated bothersome symptoms and retreatment in a considerable percent of these cases [8–11]. Thus, irrespective of the stone-related factors, endourologists should not only solely focus on the success rates but also on the presence and possible effects of RF on the psychological, functional, social life of the patients [12, 13]. Quality of life is an estimate of freedom from impairment, disability or handicap [14]. The concept of healthrelated QOL is multidimensional and includes psychosocial, physical and emotional status, as well as patient
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autonomy and is applicable to a wide variety of medical conditions [13, 15–18]. Although QOL of the cases has been well assessed and evaluated in a variety of diseases and/or procedures, to our knowledge, limited studies investigated the possible effects of RF on the QOL in patients with RF after certain stone removal procedures. Available studies on this aspect are limited to those involving patient preferences in the treatment of urinary stones, stent placement and QOL following SWL procedure or other surgical modalities [16, 19, 20]. In this prospective study we aimed to evaluate the possible effects of RF after SWL on the QOL of the treated patients on a size-related basis using Short-Form 36-item survey (SF-36) quastionnaire.
Patients and methods Between February 2012 and March 2013, a total of 86 patients (61 men, 25 women; M/F: 2.4) presenting with RF after SWL for solitary renal pelvis stones sizing 10–25 mm were evaluated in a prospective manner with a 3-month follow-up period. Patients with ureteral calculi, complex renal anatomy, transplant kidneys, medullary sponge kidneys, parenchymal calcifications, urinary diversion, cystine or struvite stones, pregnancy, bleeding diathesis or in need for anticoagulants were all excluded from the study program. Following the first session of SWL, patients were divided into three subgroups with respect to the largest RF size: Group 1 (n:30) Patients with RF sizing ≤2 mm, Group 2 (n:21) 2–≤4 mm and Group 3 (n:35) patients with RF sizing >4 mm. SWL procedure was performed under sedoanalgesia (Fentanil, 1.5 µg/kg) by an electromagnetic (Dornier Compact Sigma, Dornier MedTech Germany) lithotriptor with a maximum SW number of 3,000/session at 120 kV values. All procedures were performed on an outpatient basis and the overall stone-free (SF) status has been assessed at 3 months. Following a week after SWL, first plain KUB and sonography were performed in all cases and NCCT was performed in a case-dependant manner to assess the presence and size of the RF if needed. All cases were followed for 3 months and spontaneous passage rates, number of emergency departments (ED) visits, the amount of the analgesic required (Diclofenac sodium 75 mg IM at each referral), additional procedures for symptomatic and/or obstructing fragments and the changes in the QOL were well assessed. The impact of the RF on QOL was evaluated from different aspects after 1 and 3 months by giving SF-36 questionnaire filled at hospital conditions. To determine the significance of the differences between our sample population and those of Turkish healthy volunteers; the overall QOL scores of the subgroups were first compared
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with the scores of healthy Turkish volunteers before making the inter subgroup comparisons which has been derived from a cross-sectional study of 1,279 persons (18 years old or older) without any chronic disease during both 1- and 3-month follow-up [21]. The Medical Outcome Study SF-36 Turkish version1.0 was used to assess QOL [22]. This questionnaire consists of 36 self-administered questions that quantify QOL using eight multi-item scales: General health (GH), Physical functioning (PF), Role physical (RP), Bodily pain (BP), Vitality (VT), Social functioning (SF), Mental health (MH) and Role emotional (RE) [23].The eight scales were scored separately from 0 to 100, with a higher score being indicative of a better result, and these scores were used for analyses of the comparisons among the groups. All analyses were performed using NCSS 2007 & PASS 2008 Statistical Software program. SF-36 domains were compared among subgroups by potential predictors and significance was tested by the Student’s t test. Evaluation of qualitative data was done with Yates Continuity Correction test. Moreover, to evaluate the mean group values of normally distributed parameters in more than two subgroups One-Way ANOVA test and Tukey HD test were used for Post Hoc analysis. Significance was considered as p 4 mm in 35 cases (41 %). KUB, sonography and NCCT (when necessary) were performed in the diagnosis and follow-up of RF. Depending on the clinical course of RF additional procedures like repeat SWL, ureteroscopy with intracorporeal lithotripsy (URS) and double-J stent (DJ) were performed in symptomatic cases. Regarding the composition of the stones, analysis of data was available in 55 patients and majority of them had calcium containing stones [Calcium oxalate monohydrate in 32 (58.2 %), calcium oxalate dihydrate in 13 (23.6 %) and mixed calcium stones in 10 (18.2 %)]. Evaluation of our data revealed following findings Patients with RF ≤2 mm All 30 cases with RF sizing ≤2 mm passed fragments (in an asymptomatic manner in 25 cases) spontaneously
Urolithiasis Table 1 Evaluation of patient and stone characteristics in all groups
Number of cases n (%) Mean age (years) Male/female Initial stone size (mm)
Overall
Group 1
Group 2
Group 3
86 (100)
30 (35)
21 (24)
35 (41)
40.7 61/25 12.5 (10–25)
42.2 (20–67) 21/9 10.7 (10–13)
40.0 (25–57) 15/6 11.5 (10–17)
40.0 (22–65) 25/10 15.2 (11–25)
Group 1 (≤2 mm)
n (%)
Mean RF size (mm)
Number of cases Spontaneous passage after first session of SWL Without any symptom With clinical symptoms requiring medical management Patients with symptoms requiring intervention Overall (After 3 months) stone free
30 (35) 30 (100) 25 (83) 5 (17) 0 (0) 30 (100)
1.8 (1.2–2.0) 1.8 (1.2–2.0) 1.6 (1.2–2.0) 1.9 (1.7–2.0)
Group 2 (2–≤4 mm) Number of cases Spontaneous passage after first session of SWL
21 (24) 11 (52)
3.6 (2.2–4.0) 3.3 (2.2–3.9)
Without any symptom With clinical symptoms requiring medical management Patients with symptoms requiring intervention Required intervention in these cases ESWL URS Overall (After 3 months) stone free Asymptomatic residual fragments
3 (14) 8 (38) 10 (48)
3.2 (2.2–3.8) 3.4 (3.1–3.9) 3.9 (3.4–4.0)
8 (38) 2 (10) 18 (86) 3 (14)
3.8 (3.4–4.0) 3.9 (3.9–4.0) 3.75 (3.7–3.8)
Group 3 (>4 mm) Number of cases Spontaneous passage after first session of SWL Patients with persistent fragments(requiring intervention) Required intervention in these cases ESWL URS DJ stent insertion Overall (After 3 months) stone free Asymptomatic residual fragments
within 4 weeks. Mean size of the fragments was 1.8 mm (1.2–2 mm). Although five cases (17 %) received pain medication (Medical expulsive treatment, analgesic medication); no additional procedure was necessary in these cases (Table 1). Patients with RF sizing 2–≤4 mm Of the 21 patients in this group, 11 (52 %) passed the fragments spontaneously during the first month while symptoms necessitated additional intervention in the remaining 10 (48 %) patients. The mean size of the fragments in these two subgroups is given in Table 1. In symptomatic patients while SWL was performed in eight cases (38 %),
35 (41) 11 (31) 24 (69)
5.6 (4.1–9.5) 4.8 (4.1–5.2) 6.4 (4.4–9.5)
14 (40) 7 (20) 3 (9) 30 (86)
6.7 (4.7–6.4) 7.1 (4.4–9.5) 5.4 (4.4–5.9)
5 (14)
3.5 (1.9–4.5)
URS was done in two cases (10 %). Following SWL, however, although five cases (23.8 %) became ultimately SF, three cases had still asymptomatic RF(14 %). Last, two cases (6 %) became SF after ureteroscopic Stone removal (Table 1). Overall, while three cases (14 %) had RF the remaining 18 cases (86 %) were completely SF after 3 months. Patients with RF >4 mm Of the 35 cases in this group, while 11 cases (31 %) passed RF spontaneously within a mean time period of 3 weeks (1–4 weeks), 24 cases (69 %) had sypmtomatic fragments. While SWL was performed in 14 cases (40 %), URS was
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Urolithiasis Table 2 Mean analgesic requirement and emergency department (ED) visits in the symptomatic cases in all groups Residual fragment size
ED visit No Yes Mean analgesic required, Ort ± SD (mg)
≤2 mmd
2–≤4mme
>4mmf
n = 30 (%)
n = 21 (%)
n = 35 (%)
30 (100 %) 0 (0 %)
17 (81 %) 4 (19 %)
17 (8.6 %) 18 (51.4 %)
15.00 ± 0.58
141.00 ± 1.05
258.75 ± 2.61
p
p = 0.001a p1–2–3 = 0.001b p1–2 = 0.011c p1–3 = 0.001c p2–3 = 0.015c
a
Pearson Ki-kare test
b
One-way anova test
c
Post Hoc test: Tukey HSD test
d
Group 1
e
Group 2
f
Group 3
performed in 7 (20 %) and DJ stent insertion in three cases (9 %). Mean size of the fragments in these three subgroups are given in Table 1. Following SWL, while nine cases (26 %) became SF within 6 weeks (1–8 weeks), five cases still had asymptomatic RF (14 %). After two sessions of SWL again, although 20 cases (57 %) became completely SF, five cases (14 %) had still RF. Last, all seven cases (20 %) undergoing URS and the three cases (9 %) with DJ stent insertion became SF (Table 1). Analgesic use and ED visits Our data showed that patients with RF >4 mm required a higher mean amount of analgesic use when compared with the second and first groups of patients. Regarding the mean number of ED visits again while the mean percentage was 0 % in cases with fragments ≤2 mm, it was 19 % in 2–≤4 mm and 51.4 % in >4 mm (p = 0.001), respectively (Table 2). Data on QOL evaluated by SF‑36 survey Regarding the evaluation of patient-related QOL, first we compared the overall QOL scores in all subgroups with healthy volunteers during 1 and 3 months of evaluation. Data obtained during 1-month evaluation demonstrated significantly lower scores with respect to seven parameters (GH, PF, RP, BP, VT, SF and RE) in cases with RF; however, this difference was significantly lower for only two parameters (SF, RE) during 3 months’ evaluation (Fig. 1). Additionally, this evaluation has been performed in all subgroups in a size-based manner and while there was significantly lower scores for only two parameters (GH and BP) during 1 month evaluation (Table 3), significantly lower mean scores for all eight parameters were noted between three subgroups in a
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size-based manner where patients with larger fragments had the lowest scores during 3-month evaluation. Evaluation of the scores in a sub-group based manner showed significant differences depending on the mean size of the RF. Although evaluation of QOL parameters between first two groups (mean RF size of ≤2 mm and 2–≤4 mm) revealed a significant difference with lower scores in all eight fields of QOL in favor of larger fragments (2–≤4 mm) during 1-month evaluation, (Table 3) this diferrence was statistically significant for only three fields (GH, BP, VT and) with significance values of p = 0.035, p = 0.022 and p = 0.031, respectively. However, mean QOL score values of these two groups have been found to be similar during 3-month evaluation. On the other hand, comparison of the last two groups (mean size 2–≤4 mm and >4 mm) showed that while there was no significant difference with respect to all eight fields of QOL during 1-month evaluation, there was a significant difference with lower scores in six fields [RP (p = 0.045), BP (p = 0.001), VT (p = 0.020), SF (p = 0.026), MH (p = 0.005) and RE (p = 0.044)] in favor of patients with larger fragments (>4 mm) during 3-month evaluation. Most importantly, we noted that although the mean scores of the cases with RF sizing ≤2 mm were nearly similar to normal population values during 3-month evaluation,; cases with larger fragments (2–≤4 mm and also >4 mm) had still significantly lower scores than these cases possibly due to the stone-induced symptoms and additional procedures.
Discussion Urolithiasis is a major problem particularly in endemic countries [1, 2]. A proper management plan and efficient
Urolithiasis Table 3 Evaluation of the health-related quality of life scores in three groups as a whole during 1- and 3-month follow-up Size of residual fragment
GH 1 month 3 months PF 1 month 3 months RP 1 month 3 months BP 1 month 3 months VT 1 month 3 months SF 1 month
p
≤2 mm (n = 30)
2–≤4 mm (n = 21)
>4 mm (n = 35)
Ort ± SD
Ort ± SD
Ort ± SD
71.18 ± 14.66 78.51 ± 12.28
49.34 ± 14.58 72.87 ± 10.98
45.11 ± 12.52 64.08 ± 13.74
0.001 0.001
76.90 ± 22.15 88.90 ± 5.54
74.03 ± 12.72 88.15 ± 9.70
74.64 ± 18.81 82.91 ± 11.23
0.865 0.043
76.90 ± 16.04 88.60 ± 6.63
70.50 ± 17.32 89.32 ± 4.85
72.57 ± 15.44 80.16 ± 18.22
0.412 0.024
62.51 ± 16.47 87.16 ± 6.82
48.35 ± 19.65 88.54 ± 5.55
61.20 ± 17.62 74.39 ± 17.53
0.028 0.001
66.50 ± 18.26 83.30 ± 9.80
55.21 ± 15.05 83.44 ± 1.13
59.47 ± 16.55 72.57 ± 15.44
0.067 0.004
76.10 ± 13.56
70.50 ± 18.71
73.26 ± 15.79
0.527
3 months MH 1 month 3 months RE 1 month
88.90 ± 5.54
90.50 ± 0.00
84.98 ± 10.55
0.040
73.70 ± 12.49 88.10 ± 6.63
70.50 ± 14.14 89.32 ± 4.85
65.57 ± 17.45 78.78 ± 15.60
0.152 0.002
68.90 ± 17.24
58.15 ± 19.85
69.12 ± 15.97
0.983
3 months
88.90 ± 5.54
89.32 ± 4.85
82.22 ± 14.66
0.026
One-way variance analysis GH general health, PF physical functioning, RP role-physical, BP bodily pain, VT vitality, SF social functioning, MH mental health, RE roleemotional
stone removal are the main steps. Despite a successful Stone disintegration, however, RF after certain stone removal procedures can cause a variety of distressing symptoms with recurrent stones in about 70 % of patients within 20 years [24]. Colic pain, obstruction and recurrent infections are most commonly encountered problems [6]. Related with this subject, today little is known about the QOL of patients with RF after endourological procedures. Although the stones can be treated in a safe and quick manner with minimally invasive procedures [7] and the “SF” status is the ultimate aim, published data demonstrated that RF could be detected in a certain percent of the cases. Studies with long-term follow-up data reveal that 24–36 % of the cases will have RF up to 3 months after SWL [9, 10]. Concerning the of RF, particularly after SWL, although they were assumed as an acceptable therapeutic end point, accumulated data so far suggest that RF may grow and cause symptoms requiring auxiliary procedures [25].
Regarding the ongoing debate for the definition and the management of RF, the major issue is whether the physicians need to aggressively treat them for a completely SF status or is it possible to follow these patients closely. However, associated symptoms and morbidity casued by these fragments could constitute significant effects on patients’ QOL in different ways [4, 5]. Published data demonstrated that although the majority of the fragments may remain asymptomatic, at least a certain percent may cause serious symptoms due to acute dislodgement, obstruction and infection. They may necessitate pain management, ED visits, hospitalization, or even removal [26] that may usually significantly affect the long-term QOL of such cases. Some investigators reported that a substantial number of these cases will experience a symptomatic episode requiring additional intervention within 2 years after SWL [17, 27]. Related with this subject, in their study Raman et al. [28] showed that the size of post-PNL RF correlates with
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Urolithiasis
100 90 80 70 60 50 40 30 20 10 0 Normal healthy Turkish volunteers Overall group values at 1-month Overall group values at 3-month
#
''
# #
''
#
#
#
#
GH 71.6 51.3 70.8
PF 83.8 74.8 85.8
RP 86.3 73.1 84.7
BP 82.9 58.1 81.8
VT 64.5 60.4 78.5
SF 91 73.1 87.2
MH 71 69.2 84.1
RE 90 68.3 85.8
Fig. 1 Evaluation of the QOL scores between volunteers and overall values of the whole group during 1 and3 months. (’’, #) Statistically significant differences (p < 0.05) determined from Student t test between Normal Turkishvolunteers and residual fragments group. GH
general health, PF physical functioning, RP role-physical, BP bodily pain, VT vitality, SF socialfunctioning, MH mental health, RE roleemotional
stone-related events where larger fragments were more likely to require secondary intervention. Again, Streem et al. [27] reviewed the natural history of small (4 mm had still significantly lower scores than these cases possibly due to the stone-induced symptoms and additional procedures performed. Thus, the evaluation of QOL after 3 months is more reliable by giving the chance to evaluate the affect of additional procedures on this parameter which are mostly performed within 4 weeks after SWL. Our findings in turn again led us to discuss the possible effects of RF on the QQL of the patients and open the true importance of clinical significance of RF assessed and interpreted only based on their size (that was done in the majority of published studies so far) for discussion. Depending on the size of the RF, we should re-think about the clinical significance of them, particularly taking the bothersome changes in patients QQL into account. It was clear that as the size of the fragments increase on one side the changes in QOL became evident and on the other side the need for analgesic use and the number of ED visits increased in a significant manner. Thus, as a crucial factor, QQL alterations noted in patients with RF should be as important as the size of the fragments to outline the “clinical significance” of these fragments indicating two main facts concerning the management of stones with SWL. First the endourologists should plan a careful patient selection in a stone size-based manner to limit the possibility of RF formation after endourological intervention and management should be performed preferably by an experienced urologist. The presence as well as the size of the RF should be closely evaluated and followed after treatment. Last, taking the limited possibility of passage of relatively larger fragments (>4 mm) into account; urologists could plan to treat these larger fragments on time rather than waiting for spontaneous passage. Concerning the limitations of our study, the number of cases evaluated could be the only certain limitation. However, as this study is the first one in the literature evaluating the possible effects of RF on the QOL after SWL in a sizebased manner. we believe that our study will certainly give an idea in defining the clinical significance of the RF and their true effects on QQL, a topic which was not evaluated in detail so far.
Conclusions Despite a successful stone disintegration, relatively larger RF (2–≤4 mm and >4 mm) after SWL could significantly affect the QOL of these cases. Colic pain requiring possible ED visits and analgesic intake and the additional
procedures for fragment removal are the main causes of discomfort. A well planned and effective management by an experienced urologist should be aimed in the treatment of stones with SWL. Conflict of interest We have no conflict of interest.
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