Does the Size of Ureteral Stent Impact Urinary Symptoms and Quality of Life? A Prospective Randomized Study

European Urology European Urology 48 (2005) 673 678 Endourology Does the Size of Ureteral Stent Impact Urinary Symptoms and Quality of Life? A Prospective Randomized Study Rocco Damiano a, *, Riccardo Autorino b, Marco De Sio b, Francesco Cantiello a, Giuseppe Quarto b, Sisto Perdonà b, Rosario Sacco a, Massimo D Armiento b a Chair of Urology, Faculty of Medicine and Surgery, Department of clinical and experimental medicine, Magna Graecia University of Catanzaro, via T Campanella 202, 88100 Catanzaro, CZ, Italy b Chair of Urology, Second University of Naples, Italy Accepted 8 June 2005 Available online 1 July 2005 Abstract Objective: To evaluate the effect of stent diameter on patients symptoms and quality of life (QoL) by using dedicated questionnaires. Methods: We prospectively enrolled 34 patients with unilateral ureteral obstruction due to urinary stone undergoing to ureteral stenting (17 pts with 4.8 F and 17 pts with 6 F) before treatment of stone disease. Twenty-one patients with lower urinary symptoms from other causes were used as a control group. Two questionnaires, one on QoL and another on stent specific symptoms, were administered to patients one week after stent positioning and 4 week after removal. Results: There was a significant association between stent state and answers on pain and discomfort on QoL questionnaire. A high percentage of patients reported anxiety and depression associated with the stent. Similar significant association was found between stent state and urinary symptoms and pain. No differences in QoL and urinary symptoms and pain were detected using stents with different size. Conclusions: Ureteral stents are invariably associated with urinary symptoms and impaired QoL. We did not find any difference between stent with different size, whereas there was a tendency for stent with smaller diameter to dislodge more often. # 2005 Elsevier B.V. All rights reserved. Keywords: Ureteral stent; Symptoms; Patient satisfaction; Quality of life 1. Introduction Ureteral stenting has become a part of routine clinical practice in the treatment of ureteral obstruction. Uncontroversially, side effects and complications reported have increased compared to the past and today patients morbidity associated with stents have been identified as major problem [1,2]. Indwelling ureteral stents are considered to produce significant discomfort and it is also recognized that the degree of discomfort varies among patients. In spite of * Corresponding author. Tel. +39 336 947357; Fax: +39 961 741357. E-mail address: damiano@unicz.it (R. Damiano). improvements in stent designs and composition, objective and structured in depth assessment of the impact of the stent on patient s quality of life (QoL) has been only recently performed [3,4] and represent an important measure in clinical practice [5]. The assessment of the urinary symptoms caused by stents is not easy using clinical measures. Moreover, it has been demonstrated that validated questionnaires, commonly used to assess QoL, can have levels of precision that equal or exceed clinical measures [6]. The most common questionnaire to assess lower urinary tract symptoms (LUTS), as the International Prostate Symptom Score (IPSS), is not condition specific and 0302-2838/$ see front matter # 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2005.06.006

674 R. Damiano et al. / European Urology 48 (2005) 673 678 does not evaluate the specific impact of the stent on patients symptoms. We report our experience on the evaluation of symptoms related to indwelling double pigtail stents and their impact on patient s QoL, based on different stent diameters, using a validated QoL questionnaire and a stent symptom specific questionnaire. 2. Matherials and methods 2.1. Study population Overall, we prospectively considered 34 patients with unilateral ureteral obstruction due to urinary stone undergoing ureteral 28 cm polyurethane stent positioning before treatment of stone disease. 17 patients (group A) underwent a 4.8 F, while in the other 17 (group B) a 6 F stent. The criterion for entry into the study was unilateral placement of a double pigtail ureteral stent for urinary calculi that remained indwelling for at least 7 days. Pregnant women, patients with presence of bilateral obstruction, obstruction due to malignancy and additional procedures were excluded from the study. The stents were placed under local anaesthesia and i.v. sedation and the choice of the stent diameter was obtained by randomization tables in a single-blind fashion. A plain abdominal radiograph was routinely used to verify correct placement of the stent and dislodgement as a cause of related symptoms [7]. Patients returned a week later for shock wave lithotripsy. Twenty-one patients with LUTS (mean age 48 years, 10 males, 11 females) were used as a control group. This choice meant to confirm the common belief that that the stent state has a higher negative impact on patient s QoL than other causes of LUTS. Two questionnaires, one on the general health status (EURO QoL EQ-5D) [8], validated in Italian, and another specific on the stent related morbidity, adapted by the ureteral stent symptoms questionnaire (U-SSQ) as described by Joshi et al. [4], were administered between 7 and 14 days after the stent positioning procedure and again 4 weeks after stent removal. 2.2. QoL assessment The aim of choosing Euro QoL was to identify whether there were differences in gross defect in the physical and psychosocial well being of the patients. This questionnaire is a generic health status instrument with five domains each of health dimension (mobility, self care, usual activities, pain/discomfort, anxiety/depression) scaled from one to three score (some, moderate, extreme problems). The result is presented as the proportions of the population reporting level 1 (no problems) level 2 (some problems) and level 3 (extreme problems) for dimension. For the data analysis we considered the sum of proportions of the reported level 2 and 3 problems for each domain. Moreover, a visual analogue scale (VAS) has been used to generate a self rating of health state score on a vertical 20 cm scale having numeric values of 100 and 0. 2.3. Stent specific symptoms assessment The stent specific questionnaire, whose development was based on a literature review and also included opinion of urologists based on a day-by-day management of such patients, consisted of questions assessing urinary symptoms (4 items dysuria, hematuria, urgency and frequency), pain (site and duration) and usual problems in day to day life (with 4 items symptoms of urinary infections as pain on micturion and/or fever, need of pain killers, need of antibiotics and problems of dislodged stent). The answer to these questions were based on a four point rating scale. The scoring system for the questionnaire consist of a simple sum of the scores for individual questions in each section. There is no single score for the whole questionnaire and each section had a summary (index) score with the high scores indicate worse outcomes. 2.4. Statistical analysis The stent related impairment of QoL and urinary symptoms were the primary end-point of the study. A difference of 50% was considered to be a meaningful difference. This was based on inhouse audit data and literature analysis [4]. It was determined that stent state would be defined as responsible of the QoL and symptoms impairment should its use decrease the expected EQ VAS. To detect a difference of this magnitude with a power of 80% and a significance level of 5%, about 15 patients per arm (stented versus control groups) were required. Stratification factors included age and gender. Descriptive statistics was used to assess the differences between the results both with the stent in situ and after removal. Paired t tests were used for the studies with Euro QoL and stent specific questionnaires. 3. Results The groups were comparable in respect of sex, age, stone size and location (Table 1). In the evaluation of the general health, EURO QoL analysis revealed an association between the stent state and responses regarding the different domains, with pain/discomfort being the most bothersome significant feeling for the patients when compared with the results obtained from the control group with LUTS (p Value = 0.02 and p Value = 0.019). However, no differences were found when comparing the two stented group (p Value = 0.073) (Fig. 1). EQ-5D self rating of VAS QoL at 1 week assessment revealed a significant difference between group A and Table 1 Patients demographic data Group A (N = 17) Group B (N = 17) Control (N = 21) Mean age (range) 47.3 (29 71) 50.1 (33 68) 48 (27 66) M/F 7/10 6/11 8/13 Stone location Proximal 2 3 Medial 6 4 Distal 9 10 Stone size (mm SD) 9.4 3.1 9.7 2.7

R. Damiano et al. / European Urology 48 (2005) 673 678 675 Fig. 1. Percentage of the reported level 2 and 3 problems for each of the five EQ-5D dimensions for the three groups 1 week and after stent removal. Fig. 2. EQ-5D self rating VAS (SD) of health related QoL between week 1 and after stent removal. group B versus control (two sample t test - p Value = 0.031 and p Value = 0.039), while there was no difference in mean score indicative of gross defects in physical and psychosocial function between the two groups. Compared to the results obtained 4 weeks after stent removal and considered as baseline evaluation, at 1 week evaluation after stent positioning there was a significant increase in mean EQ VAS in both group of patients with stent of different size (p Value = 0.034 and p Value = 0.022) (Fig. 2). Moreover 4 weeks after stent removal there was not difference among all three different groups. The stent specific questionnaire revealed that pain occurred in loin region in 3 patients in group A and in 3 patients in group B, whereas in bladder region in 5 patients in group A and 5 patients in group B (Table 2). Fig. 3. Sum of the score of stent specific questionnaire for individual questions in each domain.

676 R. Damiano et al. / European Urology 48 (2005) 673 678 Table 2 Ureteral stent specific questionnaire (Group A vs. B vs. Control) NIHIL Occasional Frequent Always Urinary symptoms Dysuria 6/5/12 7/8/5 4/4/0 0/0/0 Hematuria 3/2/6 8/7/11 3/5/4 3/3/0 Urgency 3/3/13 8/6/6 6/7/2 0/1/0 1 4 times/day 5 7 times/day 8 12 times/day >12 times/day Frequency 2/3/6 5/5/8 9/9/7 1/0/0 Pain Pain site Loin 3/4/6 1/1/0 2/1/0 0/1/0 Bladder 6/5/14 2/2/1 1/1/0 2/2/0 Loin and bladder 15/15/19 2/1/1 0/1/0 0/0/1 Duration of pain 5/7/9 9/8/10 3/2/2 Common problems Symptoms of I.V.U. 7/8/17 7/8/3 2/1/1 1/0/0 Need of pain killers 3/2/2 3/3/4 9/8/10 2/4/5 Need of antibiotics 4/3/3 3/3/4 5/4/4 5/7/6 Migrated stent 13/15/21 3/2/0 1/0/0 0/0/0 Data obtained 1 week after stent positioning. Overall, stent related pain was reported in 1 site (i.e. loin or bladder region) by 16/34 stented patients (47%) and in both sites by 4/34 stented patients (11.7%). The duration of pain was continuous in 17.6% and 11.7% of group A and B, respectively, whereas it was considered frequent in 52.9% of group A and 47% of group B. After a median follow up of ten days, distal stent migration in our study resulted more frequent for the small (4,8 F) stent group (4/17 patients, 23.5%) compared to the (6 F) B group (2/17 patients, 11.7%). The analysis of the scoring system of the stent specific questionnaire demonstrated that, at 1 week assessment, total pain as well as urinary symptoms were higher for both stented groups than for the control group with statistically significant difference (Fig. 3). Moreover, compared to baseline evaluation, there was a significant difference in the main score index similarly for the patients with 4,8 and 6 F in the three domains. 4. Discussion We designed the study to allow patients to act as their own controls in terms of their baseline LUTS and tolerability with or without stent of different diameter. We expected that 1 month after stent removal symptoms would have been completely resolved and that the answer would be representative of background urinary symptoms, if present. We also selected a control group of 21 patient with LUTS to confirm the stent has a higher negative impact on patient s QoL than other causes of LUTS. Our findings confirm that ureteral stent impair objectively patient s QoL. Compared to control group, stents had a variable degree of impact on all general health domains. A high percentage of patients reported anxiety and depression with the stent. Wide ranges in the Euro QoL scores for patients with stents confirm that even amongst those with indwelling stents, some experience more side effects than others. In our experience, different stent diameter (4,8 versus 6 F) had similar negative impact on patient s QoL. Euro QoL analysis showed that while stented patients in both groups experience significant impact on general health with almost all domains being affected to some extent, no difference could be observed for either type of stent when comparing the two stented groups. Stent specific questionnaire showed a prevalence of urinary symptoms and pain between stent state and control, while, again, no difference was detected between the two stented groups. This evaluation has been obtained independent from any stone treatment that could bias the results. Candela et al. [9] compared stent diameter and composition with patient symptoms occurring from stent placed for a variety of reasons. They did not find a difference in terms of patient tolerance. Elturk et al. [10] performed a study comparing pain and irritative urinary symptoms in patients undergoing to stent positioning

R. Damiano et al. / European Urology 48 (2005) 673 678 677 of different size after ureteroscopy. They showed no differences between the studied groups. Similarly Chandhoke et al. [11] in a study conducted with patients having shock wave lithotripsy (SWL), noted no significant differences in terms of pain and irritation using stents of two different diameters. In our experience assessment of symptoms 4 weeks after stent removal represented patient s baseline status and differed significantly from the assessment obtained 1 week after positioning. Already Pollard [12] evaluating symptoms associated with ureteral stent, confirmed that the symptoms disappeared after stent removal. These results, that appear as common points of view, has not been extensively evaluated and reported in the literature, because many of the different studies suffered from important methodological flows, same enrolled small sample size and different objective response criteria, showing difference in symptoms assessed, questionnaire used and time of assessment. Clinical observations and the acquired statistics support the assumption that bladder irritation caused by retrograde manipulation and stent insertion, lead to urinary symptoms, that, together with pain, have a significant impact on other health domains and patient s day to day activities, interfering with social life and resulting in reduced QoL. A significant proportion of patients with stents experienced pain in the loin region as observed by others [13,9,14]. However, more patients with stents experienced pain in the bladder region possibly due to mechanical bladder irritation. Irani et al. stated that stents are tolerated less well by younger patients [14]. On the other hand, Joshi et al. [4] did not observe any correlation between urinary symptoms and patients age. In our study we could not perform any statistical evaluation regarding age and stents related symptoms, as the sample size was too small. Similarly, we could not verify the impact of patients height on the urinary symptoms. Alternative treatment options as percutaneous nephrostomy tubes, when applicable, are not without their problems. Mokmalji [15] demonstrated that percutaneous nephrostomy is superior to ureteral stents for diversion of hydronephrosis caused by stones in males and juveniles. Moreover patients with stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the Euro QoL analysis [3], there is no significant difference in the gross impact on the health-related QoL indicating no patient preference for either modality of treatment. 5. Conclusions Ureteral stents are invariably associated with urinary symptoms and impaired QoL. The use of a specific questionnaire could be an important step in achieving a better understanding of the ureteral stent experience from the patient s point of view. Different stent diameter (4,8 versus 6 F) have similar negative impact on urinary symptoms and patient s QoL. There was no difference between the groups in term of urinary symptoms and pain. An important practical application of our findings is the provision of an adequate patient information or counselling about ureteral stents. We believe that a significant reduction in anxiety can result if stent related symptoms are explained to the patient beforehand. 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